2 of 10 2/19/2014 9:08 AM
|
|
- Henry Tucker
- 8 years ago
- Views:
Transcription
1 1 of 10 2/19/2014 9:08 AM Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations Baxter Healthcare Corporation 12/19/13 Department of Health and Human Services Public Health Service Food and Drug Administration Los Angeles District Pacific Region Fairchild Irvine, CA Telephone: FAX: WARNING LETTER VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED December 19, 2013 WL # Dale V. Cowart, Plant Manager Baxter Healthcare Corporation Armstrong Avenue Irvine, California Mr. Mark Jackson Vice President of Quality, Medical Products Baxter Healthcare Corporation W. Illinois Rt. 120 Round Lake, Illinois Dear Mr. Cowart: During an inspection of your firm, Baxter Healthcare Corporation located in Irvine, California, investigators from the United States Food and Drug Administration (FDA) conducted an inspection from December 10, 2012 to June 4, 2013 and determined that your firm manufactures elastomeric infusion pumps and your firm contract manufactures/repacks elastomeric infusion pumps and specialty medical devices as well. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conductions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act 21 U.S.C. 321(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
2 2 of 10 2/19/2014 9:08 AM We received a response from Mr. Mark Jackson, Vice President of Quality, Medical Products, from Baxter Healthcare Corporation Round Lake, Illinois on June 26, 2013 concerning our investigator s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations that was issued to your firm. In addition, we requested additional information on July 9, 2013 regarding your firm s decision to (b)(4) of your elastomeric infusion pumps and any associated accessories by (b)(4). A response to our correspondence was received from Mr. Mark Jackson on July 18, We addressed these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following: 1. Failure to establish procedures for corrective and preventive action, as required by 21 CFR (a). Specifically, A. IM-CAPA-007 was opened in 2005 for bladder ruptures and remained open for (b)(4) days. The root causes identify (b)(4); (b)(4); and (b)(4) of the (b)(4). The corrective actions include implementing an (b)(4) and adding preventive maintenance on the (b)(4). Your effectiveness verification after three months was performed with a review of complaints which determined that the corrective actions were effective. The effective summary opened on August 5, 2005 for the Intermate and Infusor bladder ruptures states the validation document number V demonstrated that the (b)(4) of the bladders improved by (b)(4)%. Protocol document number V validated the new compounding rubber process using (b)(4) equipment with water-cooling system. A review of the documentation (protocol and records) revealed: 1. The protocol only specifies that the (b)(4) test is for information only and it does not specify a (b)(4) acceptance criterion for bladders. 2. There is no record showing 50 samples were pulled from three production lots, 3. There are inconsistencies with the production lot numbers in the protocol and final report. B. IDC-CAPA-0002 was entered on 2/26/2010 for the bladder rupture complaints with (b)(4) incidents under complaint number The CAPA remained open for (b)(4) days. The root causes identified (b)(4) ((b)(4)), the (b)(4) removal ((b)(4)),(b)(4) ((b)(4)) and manufacturing procedures and practices not always clearly defined or followed (no storage specification for (b)(4)). The corrective actions implemented for (b)(4) for the (b)(4) which was modified to include a (b)(4)] and (b)(4)]; new thermocouples were purchased and installed in the salt bath; addition of a storage specification for (b)(4); retraining of operators in (b)(4) and installation of (b)(4) on the (b)(4) equipment. Your effectiveness verification after six months of complaint trending concluded the CAPA being effective. Your effectiveness plan from 4/15/11 to 10/14/11 for IDC-CAPA-0002 was closed on 10/30/11. The Action Plan, QTS Record number states no effectiveness monitoring plan is needed. However, your firm documented a CAPA to explore opportunities to establish a test method to minimize ruptures to be performed under IDC-CAPA-004. IDC-CAPA-004 was then closed-cancelled on 8/16/12. C. IM-CAPA-0025 was entered in 7/24/2009 for increased rupture complaints with the 100 ml JD Coil Infusor products and remained opened for (b)(4) days. The root causes identified (b)(4) in the compounding process for lot number IV093008B and an (b)(4) storage period of (b)(4). A spreadsheet, attached to this CAPA lists approximately 13 production lots in which compounding lot number IV093008B was used to manufacturer finished product but no assessment was made by your firm into the impact of (b)(4) on the finished product. Also, your firm received complaint number /21/10, lot numbe 09A003, product code J2C1976J, Basal/Bolus Infusor 2ML X 2ML 6 Pack with expiration date 12/31/13 reported a problem ruptured - " (b)(4) ". Your firm s corrective action included documenting the (b)(4) between the (b)(4) changes from bladder to reservoir; (b)(4) to differentiate bladder and reservoir; (b)(4) storage time; and use of different (b)(4) for bladder and reservoir (b)(4) and screening. IM-CAPA-025 was closed after your firm identified that the corrective actions were found to be ineffective, however, your firm opened IM-CAPA D. IDC-CAPA-0004 was entered on 3/31/11 to investigate elastomeric infusion pump product ruptures. Your firm initiated several studies to identify the root cause of ruptures, however, evidence of (b)(4) and (b)(4) was the conclusion but the report found no association between ruptured bladder and (b)(4) and (b)(4). This CAPA was cancelled 8/16/12 with a statement that there is no technology to identify the rupture and it is beyond the scope of this CAPA. Then NCR number 12015PR was initiated on 02/22/12 following a (b)(4) test failure that resulted in bladder rupture in [b4] unit of Infusor LV 2 ml 2C1008KP,
3 3 of 10 2/19/2014 9:08 AM production lot numbers 12B066. The corrective action was to re-inspect under (b)(4) on 3/17/12. The NCR was closed on 3/22/12 with no preventive action taken because it made reference to IDC-CAPA Additional complaints were received after your firm s decision regarding this CAPA and NCR: Complaint number (rupture) was received in 9/21/12 and complaint number (rupture) was received 9/30/12. E. IM-CAPA-0039 was entered on 8/17/2011 for increased (b)(4) ruptures complaints for the Coiled Tube lnfusors and has been opened for (b)(4) days. There are two CAPA s associated with reservoir ruptures: CAPAs IM-0025 (closed ineffective) and CAPA-0013 is referenced in this CAPA. Your firm identified root causes to be the (b)(4)and (b)(4) of two components on the (b)(4) and the (b)(4) with the reservoir component causing ruptures. The (b)(4) measurement and (b)(4) were found to be "out of tolerance." Your firm identified that the in-process weld of the (b)(4) caused internal damage. Also, your firm confirmed that the (b)(4), (b)(4) and amount of (b)(4) used, and were (b)(4) during assembly causing the ruptures. The corrections/scope detail description states on a biweekly basis any lot identified with (b)(4) complaint incidents to be placed on hold. Your computer-generated complaint logs for dates and 12/2012-1/2013 identified complaints. Lot numbers 12F039, 12F020 and 12F001 exceeded the (b)(4) lot criteria stated in IM-CAPA-0039 but as of 5/10/13 these lots were not placed on hold. F. IM-CAPA-0026 was entered on 6/25/09 to address increasing number of complaints for leakage in the distal end (between the luer body and winged luer cap) for the lnfusor product family. Your firm received complaints of winged luer leakage after this CAPA was closed on 12/13/10. Samples sent to BRL (Baxter Regional Laboratory) identified (b)(4) on the luer body. Your investigation revealed (b)(4) on the luer body (b)(4) which was not under preventive maintenance at BC supplier. Your firm's corrective action required an inspection/sort to remove all suspect products, enhance the (b)(4), initiate preventive maintenance practices and (b)(4) the luer body (b)(4) at the supplier; initiate and (b)(4); and enhance the (b)(4) design for launch on 10/30/09. IM-CAPA-0026 documents the launch of the new winged luers starting with lots lnfusor/folfusor (10A032/2C1009KP). The CAPA was closed on 12/13/10 but several complaints were received for leaks with the enhanced designed luer cap (complaint number for lot number 12B010; complaint number for lot number 12K076; complaint number for lot number 12B018 and complaint number for lot number 12D033. G. IM-CAPA-0027 was entered on 2/4/2010 and was opened for (b)(4) days. This CAPA was opened because of out of tolerance (OOT) for the (b)(4) welders, two pieces of equipment (asset # : PRD691 and : PRD 871) on the Infusor line were identified on December 16, Your contract calibration vendor notified the firm that the equipment was out of tolerance on December 22, This welder had been used to weld the (b)(4) of the Infusors. Your firm s risk analysis for this CAPA mentioned the potential risk to be the leak and opening of the sterile pathway resulting in potential contamination, causing serious injury to the patient. Therefore, your firm documented a risk as major. Approximately 36 device lots had been manufactured from Dec (welder calibrated) to Dec (when the welder was found OOT during the annual calibration). The CAPA referenced NCR QI# , opened on 12/22/09. The NCR stated Rationale for no product impact as 100% testing is in place to detect the leaks. The correction included the Calibration vendor to adjust the (b)(4) within the manufacturer s tolerance. The product impact assessment, IM stated, no hold, no FCA and that the correction was performed pe QI IM-CAPA-0027 was opened. CAPA, IM-CAPA-0027 corrective actions included (a) Rework of lo # 09K042; (b) (b)(4) Welders were placed back within tolerance; (c) Calibration frequency was reduced from annual to six months; and (d) A clear procedure for OOT notification required from the vendor. The investigation included testing (b)(4) at (b)(4), which resulted (b)(4) device leaks (reported as (b)(4)% confidence with (b)(4)% defect) as an acceptable, based on 0 accept, AQL criteria. IM-CAPA-0027 did not address the corrective actions for lots manufactured between December 2008 and December 2009 using the Out of Tolerance welders. IM-CAPA-0027 was closed effective. H. IM-CAPA-0013 was entered on 10/18/2006 for an increased CIPM (Complaint Incidents Per Million) for JD Coiled Tube Infusors in the first two quarters of 2006, the complaints of ruptures increased to 859. This CAPA was closed effective on 03/18/2008. Your firm s corrective actions only included training employees and complaint monitoring. The adequacy of your firm s responses for 1A to 1H cannot be determined at this time because you state in your response that your firm intends to deploy a re-engineered CAPA system at your Irvine facility by August 30, 2013.
4 4 of 10 2/19/2014 9:08 AM We reviewed your firm s response for 1A and concluded that it is not adequate. Your firm states Baxter will be conducting a process validation remediation plan, but you did not provide any further details such as when this would occur and, you did not provide a copy of the process validation plan. Also, we reviewed your firm s response for item 1C and concluded that is not adequate. You failed to address approximately 13 product lots that were compounded with lot number IV093008B which your firm identified to have (b)(4). 2. Failure to establish adequate procedures for design output, as required by 21 CFR (d). Specifically,the Irvine Expiration Testing Program IR and Irvine Expiration Testing Program ( ) have not been adequately established. Your procedures specify testing: functional bioburden, pyrogen, and packaging and requires investigating out of specification. A review of the procedure, protocol and relating documentation from year 2003 to 2011 revealed the following: A. Your procedure IR Rev B (effective date 8/15/11) and (effective 10/31/07) contained mathematical errors that resulted in insufficient sample units pulled for functional testing (e. g. number of sample for yearly (b)(4) for Intermate, (b)(4), Regional Analgesia; Infusor XLV; PCM is 54 not 48) and substituted production lot units were used to continue yearly testing when the original sample units were exhausted. IR states product shall be stored at a temperature less than (b)(4) degrees F ((b)(4) degrees C) in accordance with applicable direction insert and the protocol requires storage condition normal room temperature and humidity for products. The source and environment for the substituted production lots are not documented. B. You do not maintain records documenting order/receipt of production units for expiration testing. C. You did not perform and maintain expiration testing/documentation for year D. You did not perform expiration testing for year E. Your memorandum dated 3/2/05 specifies changes made to test data and Table 2.4 of Test Stats for lots tested. Not all changes stated in the memorandum were made to the table (e.g. lowest (b)(4) for lot # and 01N911) and the other lowest (b)(4) in the table are inconsistent with raw data. F. Your Final Report 2004 Expiration Data Testing concluded as successful and met performance criteria even though four (4) of twenty-four (24) units tested of the Coiled Tube Infusor lot number 99K036 failed the (b)(4) and no investigation was conducted because the production lot had expired. G. An untitled document given to the inspectional team on 3/15/13 containing a year, protocol number, family, product code, batch, interval, specify production lot number 02M050 under families Intermate and Jackson Device. H. There were only two (2) test results recorded for lot number 03H049 in document number V I. The raw data for lot numbers 02M050, and 04M042 is dated 12/21/08 and in the Final Report document number V is dated 2/20/08. We reviewed your firm s response and concluded that it is not adequate because your firm did not address the observation related to the examples noted above. 3. Failure to establish procedures to control product that does not conform to specified requirements, as required by 21 CFR (a). Specifically, the Irvine Tier 1 Nonconformance Management Procedure, IR describes the process for identifying, segregating, investigating, correcting, documenting and disposition of product, material, processes or quality systems that do not conform to specified requirements. The procedure requires NCRs to be initiated within 3 business days from the nonconformance detection; requires documenting actions to eliminate the cause of the nonconformance to prevent recurrence; confirming effectiveness of the corrective action; and risk assessment of major, moderate or minor to determine whether the nonconformance should be escalating to a Tier II CAPA. A review of Nonconformance records (NCRs) revealed they are not opened within three (3) business days as required by the procedure. Also, the NCRs procedure IR does not define a process to cancel NCRs and appropriate actions were not taken to control product that is not in conformance to specified requirements. A. Non-Conformance report number specifies complaint number but describes an adverse event of cartilage damage of a patient reported in complaint number The event date for complaint number is 09/26/2007. The non-conformance report was opened on 09/28/12 and was canceled. NCR procedure IR does not define a process to cancel NCRs. B. NCR number was opened to address a complaint investigation of a patient who was over-infused with Morphine (complaint number , lot number 12A081, MDR reported the patient was unrousable) on July 6, 2012 and assigned on July 16, The NCR was not assigned within 3 business
5 5 of 10 2/19/2014 9:08 AM days as required by your firm s procedure. Also, the NCR risk assessment was documented as "Minor" and the reason for the cancellation was evidence of tampering and review of PMDA over the last two years found no similar complaints. The NCR was cancelled on 8/3/12. NCR procedure IR does not define a process for canceling NCRs. C. NCR number was opened on 2/17/2010 due to approximately 138 bladder rupture complaints. Also, NCR addressed approximately 89 bladder ruptures finished lot number 09M010. The NCR was closed on 1/28/2011 with a reference to IDC-CAPA-002 (Refer to Warning Letter Item number 1.B). D. NCR number was opened on 10/18/12, but not assigned within 3 business days and was not escalated to a CAPA II. The NCR was opened due to 4 complaints of ruptures reported also as MDR events for complaint numbers , , , and for production lot number 11M058. Your risk assessment classified this as "Minor". A memorandum dated 11/20/12 by the Quality Engineering Manager indicates a total of 18 rupture complaints for this lot. E. NCR number opened 3/13/12 following complaint # for ruptured bladder. The product is identified as LV250, Intermate (lot number 10K056). The NCR was assigned on 3/28/12, however, it was not assigned within 3 business days. The NCR product impact was selected as "No", with an explanation that This is an incident of a type, an LV250 rupture that occurs with some frequency: in the 24 months ending February 29, 2012, there was 13/month. Only two were classified as serious. There is no corrective and preventive action indicated and the NCR was marked "No", no related past events. However, three complaints numbers and reported ruptures and complaint number reported a separated component. F. NCR number 12001PR, Intermate LV 250, lot number 12A012 was opened on 1/5/12 for a ruptured bladder during (b)(4) test. The failure was attributed to (b)(4) determined by technology resources in Baxter Round Lake. The lot initially was reworked on 2/18/12. NCR has a checked boxed for no corrective action taken and preventive action was limited to retraining on the importance of the application of (b)(4) to the bladder and how to inspect for missing (b)(4). Two complaints for bladder ruptures (complaint numbers and ) were received for this lot. G. NCR number , LV250, was opened for rupture complaint number for lot number 11N017. An additional 10 complaints of ruptures for this same production lot have been reported. The NCR is classified "Minor" and was canceled due to no history of similar complaints and the risk to the patient is low-interruption of antibiotic therapy at home. The complaint investigation reports that the (b)(4) used was (b)(4) and was part of Tier II CAPA-IDC Further, the (b)(4) was identified as one of the potential root causes of the ruptured bladder. (b)(4) was changed and placed into production on April This information is not consistent with IDC-CAPA-0002 which states the drawing of (b)(4) is aligned to the part being manufactured and no changes are required to the drawing. Your Action Summary states the activity on (b)(4) was not necessary and was removed from the change package. H. NCR number 11031PR was opened 3/9/11 and closed on 4/3/11 for out of specification (USL 1.518) for lot Three complaints (CMPLNT , CMPLNT and CMPLNT ) for leakage were received on 7/21/11, 12/6/11 and 4/7112. The adequacy of your firm s responses for 3A to 3H cannot be determined at this time because you state in your response that your firm intents to deploy a re-engineered CAPA system at your Irvine facility by August 30, Also, you made no effort to address each of the items above and therefore, your response is inadequate. 4. Failure to record a description of changes, as required by 21 CFR (b). Specifically, your firm failed to document a reason for removing the (b)(4) measurement performed under your procedure document IR Attachment B Reservoir Test Data (effective dates 8/17/12) in change control document CP Our FDA investigators reviewed your Device History Records for reservoir lot numbers IV and IV and found your firm did not have (b)(4) measurement data. The adequacy of your firm s responses cannot be determined at this time because you state in your response that your firm intends to deploy a re-engineered CAPA system at your Irvine facility by August Also, you made no effort to address each of the items above and therefore, your response is inadequate. 5. Failure to establish procedures for acceptance activities, as required by 21 CFR (a). Specifically, A. Procedures have not been established for specifications:(b)(4), (b)(4), (b)(4), (b)(4) tests listed on Product Certification KMI Registration No BZY Review of the following available Product
6 6 of 10 2/19/2014 9:08 AM Certificates from approved and signed by quality representative states "Conforms" and the final disposition as "Acceptable". Product CodeLot NumberMfg. Date Exp. Date Product CodeLot NumberMfg. DateExp. Date J2C D057 4/24/200612/31/2008J2C1976J 12J066 9/27/20129/1/2017 2JC1976J 08N009 12/15/200812/31/2013J2C1954J 12F023 6/11/20126/1/2017 J2C1976J 09A003 1/12/200912/31/2013J2C1082J 12M002 11/5/201211/1/2017 J2C1976J O9E051 5/27/200912/31/2013J2C A028 1/9/20131/1/2016 J2C1075J 09N064 12/16/200912/31/2014J2C A016 1/8/20131/1/2016 J2C1075J 10H067 8/18/2010 6/30/2015J2C A021 1/9/20131/1/2016 J2C A021 1/9/20131/1/2016 We reviewed your firm s response and concluded that it is not adequate. Your firm did not provide an established procedure in your response. Also, your firm did not provide a timeline as to when the Baxter audit team plans to audit the Baxter Irvine facility. B. The following device history records revealed that production lots did not meet the acceptance criteria required: 1. Part number , batch #siv012813a, IV103112A, the process inspection data for PM, (b)(4) defect (Accept (b)(4), Reject (b)(4)). The batch was accepted. 2. Batch IV041912A1 and Part Number: , (b)(4) Vision Inspection (b)(4) Machine Paramete checks cut length verification (b)(4) defect on 4/23/12. The acceptance criteria are to accept at (b)(4) and reject at (b)(4). The batch was not rejected (DHR production lot #12F023). 3. Batch IV041912A1 and Part Number: , (b)(4) Inspection (b)(4) Machine Parameter Checks cut length verification 3 defects ( 10:30, and on 4/24/12. The acceptance criteria are accept (b)(4) and reject (b)(4). The batch was not rejected (DHR production lot #12F023). 4. Batch IV103112A2 and Part Number: , (b)(4) Inspection (b)(4) Machine Parameter PM, Checks cut length verification 1 defect on The acceptance criteria are accept (b)(4) and reject (b)(4). The batch was not rejected (DHR production lot #12M047). 5. Batch IV012813A and Part Number: , (b)(4) Inspection (b)(4) Machine Parameter PM, Checks cut length verification 1 defect on 1129/13. The acceptance criteria accept [b4]and reject (b)(4). The batch was not rejected. 6. Batch IV081110A and Part Number: , (b)(4) Vision Inspection (b)(4) Machine Paramete PM, Checks cut length verification 3 defects ( 11:00, 8/ The acceptance criteria accept (b)(4) and reject (b)(4). The batch was not rejected (DHR production lot #10H067). We reviewed your firm s response and concluded that it is not adequate. Your firm failed to explain why the specified batches above were not rejected because they did not meet your firm s acceptance criteria. C. The following device history records revealed that (b)(4) verification is not always performed as required by Irvine Procedure for (b)(4), IR and Irvine Procedure for (b)(4) of (b)(4), IR (b)(4) Data, Batch Number IV B, date performed 6/25/11. Instant/Final (b)(4) states Manual" and (b)(4) value states "Manual". 2. (b)(4) Data, Batch Number IV A, date performed 6/25/11. Instant/Final (b)(4) states Manual" and (b)(4) value states "Manual". 3. (b)(4) Data, Batch IV A, Stock Number ,date performed 6/25/11. Instant/Final (b)(4) states Manual" and (b)(4) value states "Manual". 4. (b)(4) Data, Batch IV A, Stock Number , date performed 6/25/11. Instant/Final (b)(4) states Manual" and (b)(4) value states "Manual". 5. (b)(4) data, Attachment # B batch number IV0807A1, (b)(4) data incomplete or missing, with notation n/a for the tests, ID, (b)(4), (b)(4), (b)(4), (b)(4) and Visual Observations of 3 samples out of 5 samples. We reviewed your firm s response and concluded that it is not adequate. Your firm provided no explanation into why operators do not follow the Irvine procedures noted above.
7 7 of 10 2/19/2014 9:08 AM 6. Failure to validate according to established procedures a process whose results cannot be fully verified by subsequent inspection and test, as required by 21 CFR (e). For example, A. Validation Protocol VP Performance Qualification (PQ) of (b)(4) and (b)(4) approved on 1/16/12 list the acceptance criteria for the (b)(4) at (b)(4)% under section However, Report Number VR titled Final Report ForThe Performance Qualification (PQ) Protocol for (b)(4) and (b)(4) (Asset No ) (Approved on 2/16/12) under section documents a deviation to the (b)(4) data. The (b)(4) result for the third lot was at (b)(4)%. Your firm did not meet the acceptance criterion for the (b)(4) at less than (b)(4)% but you stated in the overall conclusion that all exceptions and deviations were resolved and all acceptance criteria were met. B. Your firm failed to follow the protocol for Validation study #V conducted on 7/28/09, (b)(4) and (b)(4)(02-795). The raw data, Response #209 states "good" and "yes" on Attachment 1 and the Good and Bad (numbers of samples per protocol) were not used in the study. There were more Good samples used than the "bad" samples. In addition, the source for the samples (e.g. batch numbers, size of reservoir); and (b)(4) had not been not documented and Test Case Purpose: message and Alarms contains markings of "yes" and "no" for test case numbers and test case #47 and 183 indicates "N/A", and there is no documentation for test case entries #47 and 183 post entered on 5/11/11. The executive summary/conclusion states system was successfully executed and met all the design qualification, installation qualification and operational qualification acceptance criterion outlined within the phases of the validation. C. Validation study report V08-044R, (b)(4) for Infusor 2 ml/hr x 100 ml: (i) The test data and the test report do not specify lots and description of Group 1, Group 2 and Group 3 samples; (ii) six out of limits; (iii) 1 rupture and 3 blockages were not addressed in the report; and (iv) 5 omits stated on (b)(4) Results with New (b)(4) and (b)(4), (b)(4) lower score result does not meet the acceptance criteria. D. (b)(4) process for bladder formulation R603-5 and reservoirs formulation R603-8, validated under V on 04/02/2007 included qualification of (b)(4) with (b)(4), asset no: The feed rate of rubber was validated as (b)(4). A (b)(4) was purchased and placed onto the production line between (b)(4) and (b)(4). The Equipment Maintenance Work Order (EMWO) procedure was implemented in lieu of equipment validation which is checked "yes" for validation required on EMWO 369. EMWO 369 does not include (a) part number, batch record or lot number identification; (b) (b)(4) formulation (b)(4) was not included and (c) (b)(4) and (b)(4) installed and maint verified was check marked as Pass and accepted even though the summary of results, states (b)(4) were used instead of (b)(4). E. Change in the (b)(4) equipment from (b)(4) to (b)(4) used for rubber compounding was validated under Protocol V The Protocol required an equipment (b)(4)]. The (b)(4) parameter (b)(4) is listed in the Irvine Procedure for (b)(4) Process The protocol required sampling at every (b)(4) per sample for (b)(4). Raw data dated 4/12/07 does not state the (b)(4) of the equipment and there is notation on the raw data record indicating samples were collected every (b)(4) instead every (b)(4). The validation report V07-17R concluded the equipment met the validation criteria for IQ and OQ. F. Protocol for Validation Study VP : 603-8, the Protocol Report VR and Irvine Procedure for (b)(4) of Reservoirs IR are inconsistent in the required (b)(4) range. The protocol lists the acceptance specification for (b)(4). Attachment B of IR , rev C lists an (b)(4) and the same procedure lists (b)(4). Further, the validation status concluded that all acceptance criteria were met. Further, the protocol does not specify the number of production lots and sample size required. Only one production lot (no lot number listed) is specified in the Report as being used during the validation. G. Validation study V07-055, V07-055R, PQ-Irvine New (b)(4) System: The lot numbers and the test results listed in the report and of raw data did not match. Out of three test data of three models of reservoir, the lot number of one model test data did not match with the results listed on the report and one test data was reported on the final report but the (b)(4) raw data was missing. Further, the sample traceability of 50 samples, used in the (b)(4) of each lot was not included in the validation. For example: The raw data of the flow test of the reservoir, listed lot # IV , model : 2C1073KJP (lot number was crossed out and changed to IV ), with the (b)(4) of and but the final report, V07-055R for model 2C1073KJP listed lot number 07J042 and the (b)(4) of and The protocol report listed (b)(4) of model 2C1082KJP as and However, the raw data did not include any (b)(4), of model 2C1082KJP. The conclusion described that the new compounding process met all acceptance criterion of the [b4]. We reviewed your firm s response and concluded that it is not adequate because your firm did not address each item above.
8 8 of 10 2/19/2014 9:08 AM 7. Failure to validate for its intended use according to an established protocol software used as part of production and the quality system, as required by 21 CFR (i). A. There is no protocol and documentation of validation for (b)(4) used in (b)(4) prior to 2011 in your Expiration (Shelf-life) Testing Program. We reviewed your firm s response and conclude that it is not adequate. B. Compounding formulation for (b)(4), (b)(4), (b)(4) and (b)(4) used for all infusion pump bladders and reservoirs were changed and programmed into the (b)(4) equipment. There is no documented validation conducted for changes to the software. We reviewed your firm s response and concluded that it is not adequate. For item 7A above, your firm did not address conducting software validation for the software used for (b)(4). For 7B above, your firm stated that the software will be revalidated. However, your firm has not validated the newly programmed (b)(4) software. 8. Failure to establish requirements that must be met by suppliers, contractors and consultants, as required by 21 CFR (a). For example, your suppliers of (b)(4) and (b)(4) have not been evaluated per Corporate Quality Procedure titled Evaluation and Selection of Suppliers, document number CQP (Effective date June ). The Irvine Plant Manager stated that these two suppliers (b)(4) by Baxter and these two suppliers (b)(4) any Baxter supplier agreements. Your firm performs a scan of the rubber, (b)(4) per procedure specification titled (b)(4) and a Certificate of Analysis (COA) is provided by the supplier. Your firm noticed the COA s provided by the supplier contained similar test values on different batches for the following tests: (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), (b)(4) and etc from years 2005 to COA s dated 23 JUN 2005, 11 July 2005, 16 FEB 2009, 22 FEB 2010, 21 MAY 2010, and 27 FEB 2011 demonstrated similar test values. Your firm provided no documentation that the COA s provided by your suppliers are reviewed at incoming inspection. Also, your procedure CQP does not require COA s to be reviewed at incoming inspection. We reviewed your firm s response and concluded that it is not adequate. Your firm did not provide a statement that the COA s were reviewed, however, it appears in your response that you conducted a recent review of these COA s. 9. Failure to establish document control procedures, as required by 21 CFR Specifically, your firm s change request number CP , titled Irvine Procedure for (b)(4) Process document number , issue date 7/10/07 (Effective date ) describes (b)(4) into (b)(4) and feeding the product into (b)(4). This production change was not implemented for all production lots produced from years 2007 to The following production batch records indicate operators documented that the (b)(4) and (b)(4) (b)(4) were used instead of the (b)(4). A. CEMTP (b)(4) batch record IV A, R693-5, Part Number , Attachment A dated 9/29/11. B. Batch record IV A, R603-5, Part Number , Attachment A dated 9/28/11. C. Batch record IV A, R603-5, Part Number , Attachment A dated 10/5/11 (D) and R603-5; Part Number , Attachment A dated 5/11/10. The adequacy of your firm s responses to 9A to 9C cannot be determined at this time because you state in your response that your firm intents to deploy a re-engineered Change Control Management System at your Irvine facility by August 30, Failure to establish procedures to ensure equipment is routinely calibrated, inspected, checked and maintained, as required by 21 CFR (a). For example, A. Your firm s Irvine procedure for Calibration of (b)(4) document number IR (Effective dates 3/5/2009 to effective date 5/31/12) required (b)(4) at (b)(4)%, (b)(4)%, (b)(4)%, (b)(4)% and (b)(4)% but were not taken for PRD-1202 on calibration dates: 9/10/10, 9/9/11 and 9/6/12. B. Your firm s Irvine procedure for calibration of (b)(4), (b)(4), (b)(4) and (b)(4), IR , effective 01/09/2009, 31 May 2011, 08 March 2012 and 01 March 2013 were not implemented. Your procedure requires:
9 9 of 10 2/19/2014 9:08 AM 1. The use of weight that is at least (b)(4)% of the scale range. The (b)(4), (b)(4) and (b)(4), dated revealed the weight readings taken from 2.2 lbs to 20 lbs on 1/14/12 but only 2.2 lbs. to 5.0 lbs. on 7/3/12 and on 12/31/ The procedure IR included calculation and verification of (b)(4). Your firm does not document this in your calibration records. We reviewed your firm s response and concluded that it is not adequate. Your firm provided no objective evidence that there is no product impact because of the deficiencies above. 11. Failure to demonstrate in the device history record that the device was manufactured in accordance with the device master record, as required by 21 CFR Specifically, A. Part number containing component build for the infusor and bill of material was changed per Change Order CP dated 9/26/06, from Part Number (P/N) to Then a subsequent change order CP (issue date on 9/10/2009) was to replaced Part Number to The following device history records references Part Numbers , and For example, 1. Device History Record for the 2ML/Hr, 100 ML, Two day coiled tube infusor: a. Device IV , Finished device lot number 10A080, dated 1110/10 b. Device IV , Finished device lot number 09N064 dated 12112/09 c. Device IV , Finished device lot number 10H Device History Record for lot 10H067, subassembly lot number IV08110A did not include Attachments D ((b)(4)), E ((b)(4)) and G ((b)(4)) as required per your procedures IR (effective dates 08/27/2008, 03/31/2011, 08/172012). 3. Device History, Part Number , lot number IV40612A, Attachment B, Reservoir Test Data listed Out of specification test results ( and ) for the (b)(4) diameter on April 6, 2012 and reviewed and approved on April 9, Then on July 26, 2012, the initial Out of Specification were crossed out and replaced 1.05 and 1.06 (Specification is (b)(4)) and with a notation Entry Error. Your firm had no documented data to support the new replaced results. 4. Programming requirement in your firm s Irvine Procedure IR (Revision C) for the Operating (b)(4) has not been implemented for sections 7.2 and 7.4). We reviewed your firm s response and concluded that it is not adequate because you did not address the incorrect part number for each Device History Record above and attachments E and G were not provided in your response. Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, a premarket approval application for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Request for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected. Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, form occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. I your firm s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm s response should be comprehensive and address all violations included in this Warning Letter. Your response should be sent to:
10 10 of 10 2/19/2014 9:08 AM Mr. Blake Bevill Director, Compliance Branch U.S. Food & Drug Administration Fairchild Irvine, CA Finally, you should know that this letter is no intended to be an all-inclusive list of the violations at your firm s facility. It is your firm s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt action to correct the violations and bring the products into compliance. If you have any questions about the content of this letter please contact: Ms. Mariza M. Jafary, Compliance Officer, at (949) Sincerely, /S/ Steven Porter, Acting Director Los AngelesDistrict Cc: Hugo Cornejo, Acting Chief California Department of Public Health Food and Drug Branch 1500 Capitol Avenue MS 7602 PO Box Sacramento, California Page Last Updated: 02/18/2014 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies U.S. Food and Drug Administration New Hampshire Avenue Silver Spring, MD Ph INFO-FDA ( ) FDA For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive Links on this page:
Inspections, Compliance, Enforcement, and Criminal Investigations
Page 1 of 7 Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities Warning Letters 2014 Inspections, Compliance, Enforcement, and Criminal Investigations
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Page 1 of 5 Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations Jabones Pardo S.A.
More informationSoft Computer Consultants, Inc. 4/30/15
Soft Computer Consultants, Inc. 4/30/15 Department of Health and Human Services Public Health Service Food and Drug Administration Florida District 555 Winderley Place, Suite 200 Maitland, Florida 32751
More informationSandoz Private Limited 10/22/15
Sandoz Private Limited 10/22/15 Department of Health and Human Services Public Health Service Food and Drug Administration Silver Spring, MD 20993 Warning Letter VIA UPS WL: 320-16-01 October 22, 2015
More informationORACLE CONSULTING GROUP
ORACLE CONSULTING GROUP 9 Golder Ranch Rd., Ste. 1 Tucson, Arizona 9 Web Site: E-mail: 20-2-0 20-2-0 (FAX) CONSULTING MEMORANDUM QUALITY SYSTEM INSPECTION TECHNIQUE
More informationQuality Management System Manual Revision L
This Page 1 of 35 of the Quality Management System Manual If issued as a controlled copy, the serial number of this copy is Quality Management System Manual Certified to AS9100 Revision C Printed copies
More informationMeriCal Quality Profile
January 5, 2015 Dear Valued Customer, Since the implementation of new federal regulations, MeriCal Inc. has received a large volume of questionnaires and surveys regarding our services and procedures.
More informationTriangle Compounding 11/2/15
Triangle Compounding 11/2/15 Department of Health and Human Services Public Health Service Food and Drug Administration Atlanta District 60 Eighth Street NE Atlanta, GA 30309 November 2, 2015 VIA UNITED
More informationCorrective and Preventive Action Background & Examples Presented by:
Corrective and Preventive Action Background & Examples Presented by: Kimberly Lewandowski-Walker Food and Drug Administration Division of Domestic Field Investigations Office of Regulatory Affairs Overview
More informationRTP s NUCLEAR QUALITY ASSURANCE PROGRAM
RTP s NUCLEAR QUALITY ASSURANCE PROGRAM RTP operates under one quality program, whether you purchase products that are commercial grade, nuclear safety-related or industrial safety compliant (IEC 61508).
More informationISO 9001 Quality Systems Manual
ISO 9001 Quality Systems Manual Revision: D Issue Date: March 10, 2004 Introduction Micro Memory Bank, Inc. developed and implemented a Quality Management System in order to document the company s best
More informationCompany Quality Manual Document No. QM Rev 0. 0 John Rickey Initial Release. Controlled Copy Stamp. authorized signature
Far West Technology, Inc. ISO 9001 Quality Manual Document No.: QM Revision: 0 Issue Date: 27 August 1997 Approval Signatures President/CEO Executive Vice President Vice President/CFO Change Record Rev
More informationSUPPLIER QUALITY SYSTEM AUDIT
Company Name: Date: Company Address: Quality Assurance Mgr: President: Number of employees: Is your company receptive to source inspection? List all standards the quality system is based on Web Page: Company
More informationSUPPLIER QUALITY MANAGEMENT SYSTEM QUESTIONNAIRE
Company Name Street Address City, State, Zip code Phone Number Fax Company Website Email Address ORGANIZATION NAME PHONE NUMBER EMAIL ADDRESS President/CEO General Manager Engineering Manager Production
More informationIVD Regulation Overview. Requirements to Assure Quality & Effectiveness
IVD Regulation Overview Requirements to Assure Quality & Effectiveness CLIAC Jan. 2002 Statutory and Regulatory Requirements Statute: Food, Drug, and Cosmetic Act Food and Drugs Act of 1906 Food and Drug
More informationSpecialties Manufacturing. Talladega Castings & Machine Co., Inc. ISO 9001:2008. Quality Manual
Specialties Manufacturing Talladega Castings & Machine Co., Inc. ISO 9001:2008 This document is the property of TMS and may not be reproduced, wholly, or in part, without the express consent of TMS. Rev.
More informationOwner-User Pressure Equipment Integrity Management Requirements
the pressure equipment safety authority Owner-User Pressure Equipment Integrity Management Requirements AB-512 Edition 2, Revision 0 Issued 2015-06-25 Owner-user Pressure Equipment Integrity Management
More informationRevision Date Author Description of change. 10 07Jun13 Mark Benton Removed Admin. Manager from approval
Page 2 of 15 Document Revision History Revision Date Author Description of change 10 07Jun13 Mark Benton Removed Admin. Manager from approval 12Feb13 Mark Benton 08 01Oct12 Mark Benton 07 8/30/2012 Refer
More informationGxP Process Management Software. White Paper: Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations
GxP Process Management Software : Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations Most FDA violations involve one of the following: Not having procedures in a regulated area
More informationCorden Pharma Latina S.p.A. 5/20/16
Corden Pharma Latina S.p.A. 5/20/16 Department of Health and Human Services Public Health Service Food and Drug Administration Silver Spring, MD 20993 Via UPS Warning Letter 320-16-14 Return Receipt Requested
More informationUL Qualified Firestop Contractor Program Management System Elements. March 13, 2013
UL Qualified Firestop Contractor Program Management System Elements March 13, 2013 UL and the UL logo are trademarks of UL LLC 2013 Benefits to becoming a Qualified Firestop Contractor Independent, 3 rd
More informationMapping Your Success Top Non-Conformities Requiring a CAPA Process
Mapping Your Success Top Non-Conformities Requiring a CAPA Process Agenda FDA Statistics for 2012 BSI Statistics for 2012 EQMS industry benchmark data About CAPA Traits of Software Solution for CAPA 2
More informationCalibration & Preventative Maintenance. Sally Wolfgang Manager, Quality Operations Merck & Co., Inc.
Calibration & Preventative Maintenance Sally Wolfgang Manager, Quality Operations Merck & Co., Inc. Calibration: A comparison of two instruments or measuring devices one of which is a standard of known
More informationQuality Agreement Template
Quality Agreement Template Prepared by Dan O Leary Ombu Enterprises, LLC 3 Forest Ave. Swanzey, NH 03446 603-209-0600 This document is intended to form the basis for a Supplier Agreement. The document
More informationCHAPTER 7 - RECALL ACTIVITIES
CHAPTER 7 INVESTIGATIONS OPERATIONS MANUAL 2015 CONTENTS CHAPTER 7 - RECALL ACTIVITIES 7.1.1.1 - Recall SUBCHAPTER 7.1 - RECALLS... 368 7.1.1 - DEFINITIONS... 368 7.1.1.1 - Recall... 368 7.1.1.2 - Recall
More informationQUALITY MANUAL ISO 9001. Quality Management System
Page 1 of 20 QUALITY MANUAL ISO 9001 Quality Management System Printed copies are not controlled unless marked "CONTROLLED". Upon receipt of this document, discard all previous copies. Page 2 of 20 Approval
More informationQUALITY ASSURANCE MANUAL JPM OF MISSISSIPPI, INC.
QUALITY ASSURANCE MANUAL JPM OF MISSISSIPPI, INC. Hattiesburg, MS Revision E 01/19/11 Revised to ISO 9001:2008 on July 9, 2009 JPM OF MISSISSIPPI, INC. MANAGEMENT QUALITY POLICY It is the goal of JPM of
More informationCORPORATE QUALITY MANUAL
Corporate Quality Manual Preface The following Corporate Quality Manual is written within the framework of ISO 9001:2008 Quality System by the employees of CyberOptics. CyberOptics recognizes the importance
More informationCartel Electronics. AS 9100 Quality Systems Manual
Cartel Electronics AS 9100 Quality Systems Manual 1900 C Petra Lane Placentia, California 92870 Introduction Cartel Electronics, as a global supplier to the aviation, space, and space industries, has developed
More informationONTIC UK SUPPLIER QUALITY SURVEY
MAIL-IN / ONSITE This report is intended to furnish data relative to the Suppliers capability to control the quality of supplies and services furnished to Ontic UK. Please complete this Survey and return
More informationThe purpose of this Supplier Quality Standard is to communicate the expectations and requirements of Baxter Healthcare Corporation to its suppliers.
Supplier Quality Standard 1.0 Purpose The purpose of this Supplier Quality Standard is to communicate the expectations and requirements of Baxter Healthcare Corporation to its suppliers. These expectations
More informationFINAL DOCUMENT. Global Harmonization Task Force
FINAL DOCUMENT Global Harmonization Task Force Title: Quality management system Medical Devices Guidance on corrective action and preventive action and related QMS processes Authoring Group: Study Group
More informationMaking Recall Determinations
Making Recall Determinations AdvaMed January 23, 2008 Orlando, FL Edward C. Wilson, Jr., Esq. Partner Hogan & Hartson LLP (202) 637-5839 ecwilson@hhlaw.com www.hhlaw.com Michael S. Heyl, Esq. Associate
More informationCase 1:15-cv-23419-XXXX Document 1 Entered on FLSD Docket 09/10/2015 Page 1 of 8
Case 1:15-cv-23419-XXXX Document 1 Entered on FLSD Docket 09/10/2015 Page 1 of 8 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF FLORIDA UNITED STATES OF AMERICA, ) ) Plaintiff, ) ) v.
More informationQuality Management System General
Audit Date: Quality Management System General Requirement: 4.1 and 4.2.2-QMS General Verify Scope Comments/Evidence/Findings: Verify the Exclusions is applicable and justified How are the processes in
More informationQUALITY MANUAL REVISION RECORD
Page 2 of 31 REVISION RECORD Date Rev Description Jun 18, 2007 N/C Original Issue Sep 16, 2009 A Update to ISO 9001:2008 Standard. Feb 04, 2010 B Revised exclusions, removed (Except 7.3.7 from the exclusion
More informationINTEGRATED MANAGEMENT SYSTEM MANUAL IMS. Based on ISO 9001:2008 and ISO 14001:2004 Standards
INTEGRATED MANAGEMENT SYSTEM MANUAL IMS Based on ISO 9001:2008 and ISO 14001:2004 Standards Approved by Robert Melani Issue Date 30 December 2009 Issued To Management Representative Controlled Y N Copy
More informationQuality Management Systems Manual
Washington Division Quality Management Systems Manual ISO 13485:2003 DOCUMENT NUMBER 01-QM-MED REVISION LEVEL 01 PAGE 1 of 40 This manual describes the quality management systems structure at GM Nameplate
More informationSTEEL fabrication quality SySTEmS guideline
STEEL fabrication quality systems guideline Copyright 2002 by Canadian Institute of Steel Construction All rights reserved. This book or any part therof must not be reproduced in any form without written
More informationGuidance for Industry Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products
Guidance for Industry Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products U.S. Department of Health and Human Services Food and Drug Administration
More informationUNCONTROLLED COPY FOR REFERENCE ONLY
CLOVER MACHINE AND MFG. 800 MATHEW ST. #101 SANTA CLARA, CA 95050 727-3380 727-7015 fax REVISION: DATE: PAGE 1 OF 45 QUALITY POLICY MANUAL DISTRIBUTION LIST: President Purchasing Manager Vice President
More informationQuality Management System MANUAL. SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702
Quality Management System MANUAL SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702 Doc. No. G5500 Rev. 9.1 Status : APPROVED Effective: 12/11/2014 Page 2 of 23 Quality Manual Table of Contents
More information2016 > Emcure Pharmaceuticals Limited 3/3/16
Seite 1 von 7 U.S. Food and Drug Administration Protecting and Promoting Your Health Emcure Pharmaceuticals Limited 3/3/16 Department of Health and Human Services Public Health Service Food and Drug Administration
More informationAVNET Logistics & EM Americas. Quality Manual
AVNET Logistics & EM Americas Quality Manual Avnet is committed to ensuring customer satisfaction while meeting all customer and applicable legal, statutory and regulatory requirements. This is accomplished
More informationQuality Management System Manual
Quality Management System Manual Assurance ISO / AS Manual Quality Management System EXCEEDING ALL EXPECTATIONS Since our inception in 1965, Swiss-Tech has supplied the medical, aerospace, hydraulic, electronic
More informationSupplier Quality Requirements and Clauses
Supplier Quality Requirements and Clauses Supplier Quality Requirements General The following Quality Notes (QN01 through QN19) apply to and form a part of all Purchase Orders issued by Advanced Conversion
More informationSupplier Quality Agreements
Supplier Quality Agreements Dan O Leary CBA, CQA, CQE, CRE, SSBB, CIRM President Ombu Enterprises, LLC Dan@OmbuEnterprises.com www.ombuenterprises.com 603-209-0600 1 Speaker Biography Dan O Leary Dan O
More informationHow to Use the Design Process to Manage Risk: Elements of Design Controls and Why It Matters
environmental failure analysis & prevention health technology development How to Use the Design Process to Manage Risk: Elements of Design Controls and Why It Matters Kevin L. Ong, Ph.D., P.E. Managing
More informationQuality Manual. DuraTech Industries, Inc. 3216 Commerce Street La Crosse, WI 54603 MANUAL SERIAL NUMBER 1
Quality Manual Approval Page Document: QA1000 Issue Date: 5/29/1997 Page 1 of 17 Revision Date: 5/20/2013 DuraTech Industries, Inc. 3216 Commerce Street La Crosse, WI 54603 MANUAL SERIAL NUMBER 1 This
More informationDocuments, Records and Change Control
Documents, Records and Change Control Lori S. Lawless Medical Device Specialist Food and Drug Administration Baltimore District Office Lori.Lawless@fda.hhs.gov (410) 779-5442 May 13-14, 2008 Baltimore
More informationCamar Aircraft Products Co. QUALITY MANUAL Revision D
QUALITY MANUAL Revision D Gujll'y Manual Introduction The purpose of this manual is to describe the Quality Assurance Program implemented by Camar Aircraft Products Co. (hereafter referred to as C.A.P.C.)
More informationAddressing Risk in Partner / Contractor Selection and Onboarding. Michael Davidson VP Quality Systems and Compliance March 2014
Addressing Risk in Partner / Contractor Selection and Onboarding Michael Davidson VP Quality Systems and Compliance March 2014 Industry Trends Pfizer Overview Pfizer s Approach Risk Based Robust Due Diligence
More informationGuidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations
Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)
More informationQUALITY MANAGEMENT SYSTEM REQUIREMENTS General Requirements. Documentation Requirements. General. Quality Manual. Control of Documents
Chapter j 38 Self Assessment 729 QUALITY MANAGEMENT SYSTEM REQUIREMENTS General Requirements 1. Establishing and implementing a documented quality management system 2. Implementing a documented quality
More informationSupplier Quality Assurance Requirements Manual
12716 EAST PINE STREET TULSA, OK 74116 Supplier Quality Assurance Requirements Manual Approved: Mike Collins Quality Assurance Manager Precise Machining & Manufacturing 1 Record of Revisions Revision D
More informationQUALITY CONTROL MANUAL
QUALITY CONTROL MANUAL TABLE OF CONTENTS PREFACE I II III IV Title Page Table of Contents Information Page Revision Log SECTION DESCRIPTION 1.0 Introduction 2.0 Organization 3.0 Organization Chart 4.0
More informationQuality Management System MANUAL. SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702
Quality Management System MANUAL SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702 Doc. No. G5500 Rev. 9.2 Status : APPROVED Effective: 9/25/2015 Page 2 of 23 Quality Manual Table of Contents
More informationUNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY
JOYCE R. BRANDA Acting Assistant Attorney General JONATHAN F. OLIN Deputy Assistant Attorney General Civil Division U.S. Department of Justice PAUL J. FISHMAN United States Attorney District of New Jersey
More informationAuditing as a Component of a Pharmaceutical Quality System
Auditing as a Component of a Pharmaceutical Quality System Tim Fields Conducting internal audits (or self inspections) and external audits of suppliers and outsourcing operations are key elements of a
More informationMedical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance
Medical Product Development and FDA Regulations IEEE Orange County Computer Society March 27, 2006 Carl R. Wyrwa Medical Product Development and FDA Regulations Introduction Regulated FDA Overview Medical
More informationQuality Manual. UK Wide Security Solutions Ltd. 1 QM-001 Quality Manual Issue 1. January 1, 2011
Quality Manual 1 QM-001 Quality Manual Issue 1 January 1, 2011 This document is uncontrolled when printed. Please verify with Quality Management Representative 16 Dukes Close, West Way, Walworth Industrial
More informationHow To Ensure Quality Assurance
1001 Robb Hill Road Oakdale, PA 15071-3200 412/923-2670 PROCUREMENT SPECIFICATION: SUPPLIER QUALITY MANAGEMENT SYSTEM REQUIREMENTS Specification Number: ATI-QA-703, Rev 4 Date: 11/12/13 Page: 1 of 7 Written
More informationMicro Plastics, Inc. Quality Manual
ISO 9001:2008 11 Industry Lane Flippin, Arkansas 72634 QM-001-2008-F Page 2 of 39 Introduction Micro Plastics, Inc. developed and implemented a Quality Management System in order to document the company
More informationBogue Machine Company, Inc. Business Instruction
Bogue Machine Company, Inc. Business Instruction Document Title: Supplier Quality Control Requirements Document Number: Revision: Document Owner: Mark Bogue Backup Owner: Craig Bogue Parent Document: PURP-004,
More information14620 Henry Road Houston, Texas 77060 PH: 281-447-3980 FX: 281-447-3988. WEB: www.texasinternational.com QUALITY MANUAL
14620 Henry Road Houston, Texas 77060 PH: 281-447-3980 FX: 281-447-3988 WEB: www.texasinternational.com QUALITY MANUAL ISO 9001:2008 API Spec Q1, 9th Edition API Spec 8C 5 Th Edition MANUAL NUMBER: Electronic
More informationProcess Validation for Medical Devices
Process Validation for Medical Devices Dan O Leary CBA, CQE, CRE, CSSBB, CIRM, LLC 603-209-0600 OmbuEnterprises@msn.com Copyright 2010 by, LLC Process Validation for Medical Devices 1 Instructor Introduction
More informationTrackWise - Quality Management System
TrackWise - Quality Management System Focus area: Electronic Management of CAPA Systems in the Regulated Industry May 11, 2007 Yaniv Vardi VP, Operations Sparta Systems Europe, Ltd. Agenda Sparta Systems
More informationWhen printed the document is for reference only and is considered uncontrolled - refer to the Document Control System for the most current version
QM-1 SUPPLEMENT QUALITY MANAGEMENT SYSTEMS MANUAL Revision 6 Page: 1 of 6 APPROVED BY: TITLE DATE Electronic Signature on file Quality Director 10/3/15 D. Picciotti Page: 2 of 6 DOCUMENT REVISION HISTORY
More informationOverview of Medical Device Design Controls in the US. By Nandini Murthy, MS, RAC
Overview of Medical Device Controls in the US By Nandini Murthy, MS, RAC 18 controls are a regulatory requirement for medical devices. In the US, compliance with the design controls section of 21 Code
More informationSelf-Audit Checklist
Page 1 Company Name: Date of audit: Date of last audit performed: Name of person performing self-audit: Signature: Name of person responsible for quality system: Signature: Number of non-compliances: Page
More informationISO 9001:2008 STANDARD OPERATING PROCEDURES MANUAL
8200 Brownleigh Drive Raleigh, NC 27617-7423 Phone: (919) 510-9696 Fax: (919) 510-9668 ISO 9001:2008 STANDARD OPERATING PROCEDURES MANUAL ALLIANCE OF PROFESSIONALS & CONSULTANTS, INC. - 1 - Table of Contents
More informationCorrespondence between ISO 13485:2003 and the US Quality System Regulation
Correspondence between ISO 13485:2003 and the US Quality System Regulation Correspondence between ISO 13485:2003 and the US Quality System Regulation 1 Scope 1.1 General This International Standard specifies
More informationNORTH AMERICA OPERATIONS. (Fairmont and Montreal Facilities) QUALITY MANUAL. Prepared to comply with the requirements of ISO 9001:2008
WEIGH-TRONIX CANADA ULC NORTH AMERICA OPERATIONS (Fairmont and Montreal Facilities) QUALITY MANUAL Prepared to comply with the requirements of ISO 9001:2008 Meets or exceeds the requirements for design,
More informationISO 9001:2008 Audit Checklist
g GE Power & Water ISO 9001:2008 Audit Checklist Organization Auditor Date Page 1 Std. 4.1 General s a. Are processes identified b. Sequence & interaction of processes determined? c. Criteria for operation
More informationAS9100 Quality Manual
Origination Date: August 14, 2009 Document Identifier: Quality Manual Revision Date: 8/5/2015 Revision Level: Q AS 9100 UNCONTROLLED IF PRINTED Page 1 of 17 1 Scope Advanced Companies (Advanced) has established
More informationQUALITY POLICY MANUAL Document: 01-090000 Revision: E Effective Date: January 15, 2010
Section i INTRODUCTION QUALITY POLICY STATEMENT: The purpose of our business is to provide continuity of electrical power to keep businesses in business. We do this by helping clients solve their power
More informationALL PRODUCTS MFG & SUPPLY
ALL PRODUCTS MFG & SUPPLY 618 ANDERSON DRIVE ROMEOVILLE, IL 60446 PHONE: 877-255-8700 FAX: 877-255-8701 WWW. APGASKET.COM QUALITY MANAGEMENT SYSTEM MANUAL DATE: 11/20/12 REVISION 9.1 UNCONTROLLED COPY
More informationABTREX INDUSTRIES, INC. QUALITY MANAGEMENT SYSTEM MANUAL
ABTREX INDUSTRIES, INC. QUALITY MANAGEMENT SYSTEM MANUAL Project Quality Management System Status APPROVED Approved by KB Keith Byars, Vice President Owner KC Kevin Couvillion, Operations Manager Author
More informationStandard Practice for Quality Control Systems for Nondestructive Testing Agencies 1
Designation: E 1212 99 AMERICAN SOCIETY FOR TESTING AND MATERIALS 100 Barr Harbor Dr., West Conshohocken, PA 19428 Reprinted from the Annual Book of ASTM Standards. Copyright ASTM Standard Practice for
More informationSupplier Quality Assurance
Supplier Quality Assurance Preface We strive to continually improve our process performance by meeting quality objectives. It is imperative that our suppliers operate under the zero defects and 100% on
More informationLewis Ward L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 303-530-3279
510(k) Summary i '\' Submitted by Contact Person: EZ-Blocker B.V. Delftechpark 26 Delft 2628 XH 2, The Netherlands6911 Lewis Ward L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 303-530-3279
More informationQuality Manual TABLE OF CONTENTS APPROVAL SIGNATURE PAGE 1.1 1 AMENDMENT RECORD 1.2 2 SCOPE 2.0 3 EXCLUSIONS 2.1 3
TABLE OF CONTENTS DESCRIPTION SECTION PAGE INTRODUCTION 1.0 1 APPROVAL SIGNATURE PAGE 1.1 1 AMENDMENT RECORD 1.2 2 SCOPE 2.0 3 EXCLUSIONS 2.1 3 CORPORATE POLICY 3.0 3 QUALITY MANAGEMENT SYSTEM 4.0 4 GENERAL
More informationCOMPLIANCE BY DESIGN FOR PHARMACEUTICAL QUALITY CONTROL LABORATORIES INSIGHT FROM FDA WARNING LETTERS
COMPLIANCE BY DESIGN FOR PHARMACEUTICAL QUALITY CONTROL LABORATORIES INSIGHT FROM FDA WARNING LETTERS Primer CONTENTS INTRODUCTION...3 QUALITY AND COMPLIANCE IN QUALITY CONTROL LABORATORIES...5 Compliance
More informationFood and Drug Administration, HHS Pt. 212
erowe on DSK2VPTVN1PROD with CFR Food and Drug Administration, HHS Pt. 212 investigation was found not to be necessary and the name of the responsible person making such a determination. [43 FR 45077,
More informationCity of Raleigh Public Utilities Department. Wastewater EMS Manual
City of Raleigh Public Utilities Department Wastewater EMS Manual TABLE OF CONTENTS PAGE 2 Wastewater EMS Manual Table of Contents Management Direction 1) EMS Manual 2) Management Policy Planning 3) Process
More informationMINIMUM AUTOMOTIVE QUALITY MANAGEMENT SYSTEM REQUIREMENTS FOR SUB-TIER SUPPLIERS
MINIMUM AUTOMOTIVE QUALITY MANAGEMENT SYSTEM REQUIREMENTS FOR SUB-TIER SUPPLIERS CONTENTS 1. CONTROL PLANS 2. PROCESS APPROACH 3. PERFORMANCE 4. INTERNAL AUDITING 5. CONTROL OF NON-CONFORMING PRODUCT 6.
More informationSUPPLIER QUESTIONNAIRE
SUPPLIER QUESTIONNAIRE January 17, 2014 Dear Valued Customer, It is Summit Aerospace Inc., policy to respond in a timely fashion to every regulatory and quality inquiry as presented by our current and
More informationLife (or is it really?) Under a Consent Decree
Life (or is it really?) Under a Consent Decree Steven Niedelman Lead Quality Systems & Compliance Consultant King & Spalding LLP 1700 Pennsylvania Ave., NW Washington, DC 2006 202-626-2942 sniedelman@kslaw.com
More informationCQR-1 CONTRACTOR QUALITY REQUIREMENTS for CONSTRUCTION SERVICES
1.0 SCOPE CQR-1 CONTRACTOR QUALITY REQUIREMENTS for CONSTRUCTION SERVICES This document establishes the minimum quality program requirements for a contractor providing equipment, material, and construction
More informationISO/IEC 17025 QUALITY MANUAL
1800 NW 169 th Pl, Beaverton, OR 97006 Revision F Date: 9/18/06 PAGE 1 OF 18 TABLE OF CONTENTS Quality Manual Section Applicable ISO/IEC 17025:2005 clause(s) Page Quality Policy 4.2.2 3 Introduction 4
More informationAudit Report in the framework of the APIC Audit Programme
Audit Report in the framework of the APIC Audit Programme Company Location Address Country Subject of Audit Audit Date Auditor (lead) Co-Auditor(s) Participants Signature of Auditor(s) Lead Auditor Co-Auditor
More informationOctober 28, 2015. Cavex Holland Bv Mr. Richard Woortman Manager Technical Services Fustweg 5 Haarlem, 2031CJ The NETHERLANDS
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 28, 2015 Cavex
More informationInstallation and Operational Qualification Protocol (Reference: SOP )
Project Name Equipment Process Line/Location Project Number Serial Number Model Number Protocol number WRITTEN BY: REVIEWED BY: Position APPROVAL TO EXECUTE: Position: PROTOCOL COMPLETION APPROVAL: Position:
More informationPurchase Order Clauses and Conditions
Purchase Order Clauses and Conditions All purchase orders for materials, special processes, machining and fabrication services and end items are subject to the following requirements: General Requirements:
More informationISO 13485:201x What is in the new standard?
ISO 13485:201x What is in the new standard? Eric Finegan, Quality Mgr, BTE Technologies, Inc. 2015-09-10 1 Presentation Slides This slide deck is the presentation performed on 2015-09-10. A more detailed
More informationINTRODUCTION: PURPOSE:
UMBRA CUSCINETTI, INC. 2916 100 th Street SW Everett, WA 98204-1340 USA 425-743-2577 FAX: 425-347-0682 Printed versions may not be the latest. Suppliers shall utilize the latest version which can be found
More informationPharmaceutical Wholesaler Site Inspection Checklist
Pharmaceutical Wholesaler Site Inspection Checklist Date and time of inspection: Legal business name and plant name: Location (address): Phone number: Fax number: Email address: Web site URL: Contact Person:
More informationFINE LOGISTICS. Quality Manual. Document No.: 20008. Revision: A
FINE LOGISTICS Quality Manual Document No.: 20008 Revision: A 20008 Rev. A FINE LOGISTICS, Quality Manual Page 1 of 24 Quality Manual: Table of contents Number Section Page 1. GENERAL 3 1.1 Index and revision
More informationDesign Verification The Case for Verification, Not Validation
Overview: The FDA requires medical device companies to verify that all the design outputs meet the design inputs. The FDA also requires that the final medical device must be validated to the user needs.
More informationCAPA - the importance of data analysis
CAPA - the importance of data analysis Presented by: Sue Jacobs QMS Consulting, Inc. 1 847 359 4456 sue@qmsconsultant.com QMS Consulting, Inc. 2007 1 Topics Regulatory Requirements Design Controls and
More information