AIB International GMP Inspection Results Report

Transcription

1 AIB International GMP Inspection Results Report Consolidated Standards for Inspection: Prerequisite and Food Safety Programs Contacts Website US Office: 1213 Bakers Way PO Box 3999, Manhattan, KS (785) (800) Fax (785) UK Office: PO Box 11, Leatherhead, Surrey, KT22 7YZ Fax

2 The AIB International Consolidated Standards for Inspection are statements that represent key requirements that a facility must meet in order to keep products manufactured, processed or handled in a facility wholesome and safe The Standards reflect what an inspector would expect to see in a facility that maintains a food-safe processing environment This report details the findings from an AIB International inspection against the Consolidated Standards The document contains the following sections: Document Section Score and Rating Participant Names Facility-Specific Questions Location Matrices Findings with Risk Additional Comments Standards without identified Risks or Findings Standards Not Applicable x Description of the facility x Number of findings and related risks x Category scores and total score x Rating Description Personnel from the facility who accompanied the inspector Technical information about a facility For example: bulk materials used, temperature control equipment used Two matrices which categorize findings by Category and Risk Descriptions and recommendations related to all findings Comments made by the inspector that have no risk assessment Standards that are applicable to the inspected facility, but based on random review and observation samplings at the time of the inspection, the facility appears to be meeting requirements Standards that are not applicable to the inspected facility 2 of 23

3 The official version of this report is a certified pdf issued by AIB International Score and Rating Inspection Information: Facility Name Standard Used Prerequisite and Food Safety Programs Facility Address 2300 Sitler St Bld 687 Memphis, Tennessee United States Date(s) of Inspection Audit Type Inspection Type 25-Jun-2013 GMP Scored Products Produced Single Serve Food Co-Packer Announcement Type Account # Expected Scope Yes Reinspection No Variations From Expected Scope Terminated No Score Category Minor Issues Noted ( ) Improvement Needed ( ) Serious ( ) Unsatisfactory <= 135 Operational Methods and Personnel Practices Maintenance for Food Safety Cleaning Practices Integrated Pest Management Adequacy of Prerequisite and Food Safety Programs Total Score 935 Scores Disclaimer: AIB International Inc states that this report as dated and provided herein is to be construed as its findings and recommendations, category scores, total score, and rating A passing score of 700 and above is not a certification of the facility, products, or programs AIB International Inc does not accept or assume responsibility for the Prerequisite and Food Safety Programs in effect with the customer named on the title page of this report (the customer) AIB International Inc is only reporting the food safety conditions of the customer as of the date of this report and assumes no responsibility or liability as to whether the customer does or does not carry out the recommendations as contained in this report

4 Participant Names Name Role Inspection Closing Meeting Melvin Williams Line Lead Person Yes - Mike Anderson Co-Pack Supervisor Yes Yes Nancy Mendes HR Manager Yes Yes Rob Taylor Outside PCO Yes - Robert Keskey President Yes Yes Melvin Pleasant Auditor Yes Yes 4 of 23

5 Facility-Specific Questions # Question Comments 111 Does the facility use processing aids? No 111a State the processing aid(s) used 111b Are processing aids segregated from non-food materials? 111c Is food approval documentation provided? 113 Does the facility use bulk dry materials? No 113a State the bulk dry materials received 113b Provide the screen size of the sifter 113c State the frequency of screen and tailings checks 114 Does the facility use bulk liquid materials? No 114a State the bulk liquid materials received 114b State the locations of the strainers 114c State the frequency of strainer inspections and if they are documented 115 Are foreign material control devices used? No 115a List the devices used 115b Are they present on all lines? 115c List the specific devices tested during the inspection 122 Does the site have temperature controlled areas such as coolers and freezers? 122a State the temperatures noted at the time of the inspection State if coolers are provided for quality or food safety purposes 122b State the method of temperature monitoring (manual or continuous) 122c State if an alarm system is present 125 Are cans, bottles, or other rigid packaging materials used at this facility? No 125a What is the rigid packaging used (cans, bottles, drums)? 125b State how they are cleaned prior to filling (water, air rinse, etc) 125c State if the systems were functional No 5 of 23

6 125d State the maintenance frequency and if records were maintained for this equipment 32 Does the facility use sanitizers on food contact surfaces? Yes 32a Is sanitizing followed by a potable water rinse, where required by the sanitizer label? 32b Is the sanitizer concentration verified? Titration System 32c Are corrective actions documented when results are not in compliance with label directions? 37 Are CIP systems in use at the facility? No 37a Are CIP records and recording charts maintained and current? 37b Are CIP records and recording charts reviewed to ensure the system is functioning as required? 43 Does the site manage their pest control program under other guidelines? 43a State the guideline used 44 Are IPM services provided by a contractor? Yes 44a State the name of the service provider James Pest Management 45 Does the site require the use of IPM professionals (ie, use of restricted use pesticides and/or state or national government regulations)? If yes, please state the reason 45a State the expiration date of the PCO license(s) 12/31/14 Yes Yes No Yes, State regulated 45b If licensing of the PCO is not required, were training records current? PCO Certification Required 45c State the expiration date of the business license 10/1/13 45d State the expiration date of the certificate of insurance 7/1/13 46 Were pesticides used at this facility? No 46a List the names of the pesticides used, at a minimum, in the last 6 months or since the last AIB Inspection No pesticides used at this point 46b Were current labels provided for the pesticides reviewed? Labels for pesticides approved to be used at facility on file 46c Were current chemical safety data sheets provided for the pesticides reviewed? 52 Who was assigned responsibility for food safety at the facility? Co-Packing Supervisor Yes 6 of 23

7 52a 52b Does the facility have a current license to produce, manufacture, or store food products (local health department, state, or other agency)? Has the site implemented procedures to meet regulatory requirements (ie, allergen labeling and control, Reportable Food Registry, Food Safety Modernization Act, etc)? 510 Does the site have a documented Microbiological Control Program in place? 510a State if testing is for sanitation, environmental, raw materials/finished product 510b State the microorganisms tested for 510c 510d 510e If the facility is testing for pathogens, indicate if the testing is environmental only or if testing is done for raw materials, finished products, or food contact surfaces If the site tests for pathogens, is the product or raw material placed on hold and not released until results indicating the food safety of the product have been obtained? Are documented disposition procedures and records in place for materials that test positive for pathogens? 510f State if an in-house or outside lab is used 510g If an outside lab is used, are they accredited? List the accreditation body 511 Does this country have allergen regulations or does the site ship to countries with allergen regulations? 511a State the allergens handled at this facility 516 Has the site been inspected by a regulatory agency in the past year? No 516a State the name of the agency and the date of the inspection 516b State if the facility addressed findings identified in the regulatory inspection 522 List the materials for which specifications were reviewed (Sample a minimum of one raw material, one food contact packaging material, and one finished product where possible) 523 List the materials for which COA's or letters of guarantee were reviewed (Sample a minimum of one raw material, one food contact packaging material, and one finished product where possible) No Yes No Yes Finished Product Packaging Film Finished Product packaging Film 7 of 23

8 524 Does this process have a kill step? No 524a State the kill step 525 Is there a HACCP program in place? Yes 525a List the CCP's No CCP's 525b State if the plan has been validated and who did the validation Yes, Co-Packing Supervisor 525c State the date of the most recent assessment 4/29/13 525d State the names of the products falling under regulatory HACCP produced or stored at this facility 526 Does the site do specialized testing to meet country or regulatory requirements (ie, pesticide residues, genetically modified organisms, heavy metals, radioactivity, allergens, mycotoxins, etc)? 526a State the specialized testing completed at this facility 529 How does the facility use potable water, ice, or steam for product contact? 529a State the source of the potable water supply (well, city, etc) City 529b State the source of the records indicating potability Memphis Light, Gas & Water Division 529c Is ice made in-house or purchased? 529d 529e List the source of testing records for ice and if they indicated that it was potable Is food approval documentation provided for chemicals used for the generation of steam for food contact? 529f List the source of testing records for steam used for product contact 529g State if the back flow prevention devices are checked for function and provide the last date of testing No No Facility is located in an industrial park, main water line from city is the responsibility of the landlord The facility had a back flow on its water line with documentation from certified plumber that back flow cannot be tested only replaced when it malfunctions 8 of 23

9 Findings by Location and Category Locations Operational Methods and Personnel Practices Maintenance for Food Safety Cleaning Practices Integrated Pest Management Adequacy of Prerequisite and Food Safety Programs Facility Overview Outside Grounds and Roof Packaging Production Shipping Area Totals by Category Totals by Location Locations Findings by Location and Risk Minor Issues Noted Improvement Needed Serious Unsatisfactory Facility Overview Outside Grounds and Roof Packaging Production Shipping Area Totals by Risk Totals by Location 9 of 23

10 Findings with Risk # Risk Standard Standard # Requirement # Location 1 Improvement Needed (IN) Pest Prevention Shipping Area Gaps greater than Quarter in or 6 mm were noted in some areas Gaps greater than Quarter in or 6 mm could allow pest access into the facility The large overhead door used to bring in equipment into the facility shipping dock area had a gap at the top of the door The outside contractor did not put the brush seal at the top of the overhead door during the installation of brush seals on the door Recommendation: The top brush seal should be installed to prevent pest entry into the facility Also the facility should initiate an inspection procedure for any work done by outside contractors to insure the work is completed to company specifications 2 Improvement Needed (IN) Pest Prevention Shipping Area Gaps greater than Quarter in or 6 mm were noted in some areas Gaps greater than Quarter in or 6 mm could allow pest access into the facility The bottom concrete threshold of the overhead door used to bring in equipment next to the product shipping dock was not smooth preventing the bottom seal of the overhead door to fit securely, creating a gap between the seal and concrete threshold Recommendation: The concrete threshold on the floor base under the overhead door should be resurfaced and made smooth to allow the bottom seal of the door to securely fit eliminating the gaps at the bottom of the door 3 Improvement Needed (IN) Equipment and Utensil Construction Packaging Not all equipment and utensils were designed and constructed of materials that were easily cleaned and maintained The filler machine had a gap in the top film/filler cover which could allow overhead contamination Recommendation: The top Lexan cover over the film/filler needs to have the open section of the cover closed to prevent any potential contamination The design of the cover should include a vent to allow the heat being generated in the filler/film area to escape to prevent condensation from building in the area which could effect the sealing process 4 Improvement Needed (IN) Training and Education Facility Overview Defined requirements for ensuring of understanding and comprehension of training were not addressed for all of the Prerequisite and Food Safety Programs Recommendation: The facility should conduct exit criteria testing for all employees when they are hired to insure they have a good understanding of the product safety training materials 5 Improvement Needed (IN) Preventive Maintenance Program Production A partially developed Preventive Maintenance Program and work order system was implemented for this facility The equipment covering and building deficiencies noted during the audit to prevent contamination and pest control issues should be evaluated by the product safety committee Recommendation: The product safety committee and engineering department should talk to the filler manufacturer concerning the exposure on the filler machine which could allow contamination risks Also the engineering department should talk to the building landlord about the needed repairs on the overhead door and building outside walls which could allow pest entry into the manufacturing building 10 of 23

11 6 Minor Issues Noted (MI) Finished Product Transportation Facility Overview The facility is transporting the finished product to the shipping trailer and must open the production/storage room to move the product to the shipping dock for load-out No procedure was in place to insure the load-out door closed when production/storage room door opened Recommendation: The facility should write an SOP that states the shipping dock door cannot be open at the same time as the production/storage room door The SOP should state that if one door is open the other door must be closed, so that pallets for shipment are moved to the shipping dock and staged when one of the doors is closed to prevent possible pest entry into the production/storage room 7 Minor Issues Noted (MI) Walls Outside Grounds and Roof Holes or cracks were noted in wall surfaces The shipping dock exterior wall did not have pest protection on the surface of the wall The wall surface had holes in the surface of the wall, making the surface very rough and not smooth Recommendation: The shipping dock exterior wall should have a stainless steel flashing or epoxy paint installed on the surface of the wall to assist in the prevention of pest entry into the facility 8 Minor Issues Noted (MI) Self-Inspections Facility Overview Down time was not included in the self-inspection program The Facility is a new operation and should incorporate down time as a procure Recommendation: The facility is a new operation and has not begun formal operations, when operations begin down time assessments should be done of the facility and manufacturing equipment 9 Minor Issues Noted (MI) Food Defense Program Facility Overview The Food Defense Plan did not include all elements as defined in this Standard Recommendation: When the facility is fully staffed formal training should be given all employees regarding the food defense program and all sections of the program 11 of 23

12 Additional Comments # Risk Standard Standard # Requirement # Location 1 Storage Conditions Packaging and finished products were inspected for signs of infestation on a regular basis 2 Storage Conditions The facility did not receive product returns, any product returns are sent back to the manufacturer The co-packer would only be contacted by the manufacturer who is their customer 3 Storage Conditions Segregation of packaging materials from finished products was observed 4 Raw Material/Finished Product Inventory Ingredients and packaging materials were rotated on a First-In, First-Out basis The facility will package the product when received from their customer and their process will be JIT 5 Pallets Slip sheets were used on pallets and between pallets to protect materials from damage, as required by the customer 6 Sampling Procedures Finished product samples will be taken at the facility Documented sampling procedures to prevent contamination of the product and the sample taken were defined for the facility 7 Raw Material Transfer Packaging is inspected and cleaned prior to entry into processing areas 8 Product Identification Work-in-progress and finished product materials were properly identified and dated 9 Finished Product Transportation Written transportation breakdown procedures were on file at the product manufacturer, distributor or shipping company The co-packer sends its packaged product back to the manufacturing plant for distribution 10 Hand Washing Facilities Single use towels were used at this facility 11 Hand Washing Facilities Purchased hand sanitizers were provided 12 of 23

13 12 Washrooms, Showers, and Locker Rooms A defined locker inspection program was documented and was to be carried out every six months 13 Personal Hygiene Hand washing practices were periodically monitored for effectiveness, the program will be performed every six month Work Clothes, Changing Facilities, and Personnel Areas Personnel were observed wearing suitable clothing or uniforms that were clean Any person working in the processing/packaging room wear lab coats Work Clothes, Changing Facilities, and Personnel Areas Protective clothing was by a contract service Health Conditions Cuts and grazes were covered by metal detectable bandages 17 Filling, Capping and Sealing Performance of filling and sealing operations appeared to be consistent with defined procedures 18 Security Equipment Some measures were taken to maintain facility security Security strategies included controlled gate access, controlled parking, locked doors, limited access to sensitive areas, surveillance cameras, guard services or security patrols of industrial park, truck seals/locks, employee screening, and awareness and training programs 19 Air Makeup Units Filters were in place in air makeup units which were rated MERV 8 20 Cross Contamination Prevention Partitions, doors, or other barriers were used to segregate cleaning areas from production areas 21 Integrated Pest Management (IPM) Program Responsibilities were defined for the IPM contractor 22 Facility Assessment The annual facility assessment was documented and current, performed 3/13/13 23 Credentials and Competencies Regulation does require certification or licensing of IPM personnel Certification documentation and training records were provided and current 13 of 23

14 24 Credentials and Competencies Evidence of competency of the service provider was provided through the current license 25 Trend Analysis Service records were documented and reflected current levels of pest activity and recommendations for Corrective Actions No pest activity was noted during the initial servicing performed in the facility 26 Insect Light Traps ILT light tubes were changed on an annual basis at the beginning of the active season, lights installed 6/25/13 27 Training and Education Annual refresher training was provided and current, performed 6/21/13 28 Allergen Control Program A documented Allergen Control Program was in place to address the allergens used or handled at this facility The facility presently does not have any allergen containing products 29 Glass, Brittle Plastics, and Ceramics Program Included in the policy was a procedure to handle any breakage in the facility A list of all essential glass, brittle plastics, and ceramics was developed, and scheduled inspections were conducted semi-annually 30 Recall-Withdrawal Program The mock recall exercise included the first level of distribution outside of the control of the facility The facility has not done a mock recall since no product has been manufactured or packaged 31 Recall-Withdrawal Program The written Recall-Withdrawal Program included Recall-Crisis Management team contact information, roles and responsibilities of team members, location of the Traceability Program, key regulatory agency contact information, supplier and customer emergency contact information A sample recall-withdrawal notification letter was on file from the company who owns the packaging line technology 32 Specification Program Appropriate specifications were on file for food contact packaging materials and finished products evaluated during the inspection 33 Letters of Guarantee or Certifications Letters of Guarantee or Certifications for received materials and finished products were on file and current for materials reviewed during the survey All product presently being packaged are sample/research packages not for sale 34 HACCP Program A Hazard Analysis Critical Control Point (HACCP) Program was developed and implemented for processes and process lines and incorporated Prerequisite Programs The risk analysis found no CCP's in the present packaging process 14 of 23

15 35 Release Procedures Release procedures were defined for raw materials or finished products used at this facility The facility co-packs for various manufacturers, they receive the product to be packaged and once packaged it is returned to customer for sale and distribution 36 Water Quality No water, ice, and steam water were used for food contact 15 of 23

16 Standards without identified Risks or Findings Based on random review and observation samplings at the time of the inspection, the facility appears to be meeting the requirements of the following Standards: Standard Standard # Standard Goal Rejection of Shipments/Receipt of Dry Goods Rejection of Shipments/Receipt of Perishables 11 Random review of records and programs related to safeguarding of food products by identifying and barring entry to potentially contaminated raw materials indicate they met the requirements of the standard as applicable to this site 12 Random review of the records and programs related to receipt of perishable products by identifying and barring entry to potentially contaminated raw materials indicate they met the requirements of the standard as applicable to this site Storage Practices 13 Materials appeared to be stored in a way that met the program requirements as defined by this site, as well as the applicable requirements in the standard Storage Conditions 14 Raw materials and finished products appeared to be stored in a clean storage area and were protected from contamination as observed during the inspection Raw Material/Finished Product Inventory 15 Raw material and finished product inventories appeared to be maintained at a reasonable volume Random review of materials did not identify aged or infested materials during the inspection Pallets 16 Pallets examined were found to be clean and well maintained Sampling Procedures 110 Sampling procedures were defined and developed with consideration to protection of product Raw Material Transfer 112 Observation indicated that raw materials were transferred, handled, and managed at the time of inspection to prevent contamination of materials This included transfer of materials to point of use and transfer of materials to secondary containers as applicable to the facility Foreign Material Control Devices 115 Foreign material control devices, such as metal detectors and magnets, were installed to provide foreign material control Testing of the devices in service during the inspection and random review of the documentation of checks of these devices and Corrective Action documentation indicated that the Foreign Material Control Programs were being followed as defined for the facility Waste Material Disposal 116 Waste material and waste material removal were managed to avoid product contamination Product Identification 118 Random review indicated that raw materials, rework, work-in-progress, and carry-over as applicable to the facility were identified to prevent misuse Workspace Arrangement 119 Workspace areas reviewed during the inspection were found to be clean and well maintained Hand Contact 121 Hand contact with product observed during the inspection was limited where possible and 16 of 23

17 practical to prevent contamination Cross Contamination Prevention 123 Incompatible or hazardous materials observed during the inspection appeared to be segregated and handled to prevent product contamination Hand Washing Facilities 127 Hand washing facilities examined during the inspection appeared to be appropriately located, functional, and stocked to allow hand washing to occur Washrooms, Showers, and Locker Rooms 128 Employee welfare areas examined were maintained in good condition Personal Hygiene 129 No personal hygiene practices issues were identified during the inspection Work Clothes, Changing Facilities, and Personnel Areas 130 Appropriate clothing or uniforms were observed to be clean and in good condition Changing facilities were provided Personal Items and Jewelry Control 132 No issues with the control of jewelry or personal items were identified during the inspection Health Conditions 133 Health policies were defined for the facility No issues that were inconsistent with these policies were identified Non-Facility Personnel 134 Non-facility personnel were observed to be in compliance with the facility defined GMP Programs Multiple-Service Shipping Containers 135 Multiple service shipping containers appeared to be cleaned and maintained to prevent contamination of products Glass Container Breakage 136 When glass containers were broken, procedures were in place and appeared to be effective in dealing with breakage issues Filling, Capping and Sealing 137 Monitoring of filling, capping and sealing operations appeared to be monitored and consistent with defined specifications Facility Location 21 No evidence of issues from local activities or the facility location were identified during the inspection Outside Grounds and Roof 22 Facility grounds appeared to be well maintained No issues were identified Security Equipment 23 Physical security measures were implemented at this facility Layout 24 No issues with placement of equipment and structures were identified Appropriate access for cleaning, inspection, and maintenance activities was noted Floors 25 Floor surfaces observed during the inspection were found to be in good condition Ceilings and Overhead Structures 28 Overhead structures that could be examined were found to be clean and in good condition Glass, Brittle Plastics, and Ceramics Control 29 No issues with glass, brittle plastics, or ceramics were identified during the inspection Air Makeup Units 210 Filters and screens examined during the inspection were found to be well maintained and in good condition 17 of 23

18 Leaks and Lubrication 212 Catch pans or other devices were provided to protect product from contamination from lubrication or leaks Lubricants 213 Food-grade lubricants were identified for use on food processing and packaging equipment and were labeled and segregated from non food-grade lubricants Cross Contamination Prevention 214 Segregation of operations based on process flow appeared to be practiced as observed during the inspection Temporary Repair Materials 216 Temporary repairs noted during the inspection were consistent with the facility defined program Compressed Air/Product Contact Gases 218 Compressed air or other gases were used in contact with product or product contact surfaces Random review of records and observation indicated that filters were maintained or that purity was suitable to prevent contamination of product or product contact surfaces Transporting Equipment 219 Transporting equipment appeared to be well maintained at the time of the inspection Parts Storage 220 Parts were found to be clean and properly stored at the time of the inspection Hand Washing Facilities Design 221 Hand washing facilities were provided and were observed to be operational during the inspection Cleaning 31 Cleaning appeared to be completed in a way to prevent contamination of raw materials, products, and equipment Food Contact Cleaning Compounds and Sanitizers 32 Approval and verification procedures were in place for cleaning compounds and sanitizers used at the facility for food contact cleaning Approval documentation was provided for the chemicals that were selected and reviewed Equipment and Tools 33 Cleaning tools and equipment appeared to be managed and maintained to prevent product contamination No issues were identified Daily (Housekeeping) Cleaning 34 No issues were identified with daily housekeeping practices observed during the inspection Product Zone Cleaning 35 Review of cleaning of product contact surfaces observed during the inspection indicated that these processes appeared to be effective No issues were observed or identified Non-Product Zone and Support Area Cleaning Integrated Pest Management (IPM) Program 36 Non-product zone and support area cleaning appeared to be completed No issues were identified 41 A written IPM Program outlining controls and processes to minimize pest activity were defined Facility Assessment 42 An annual assessment of the IPM Program was documented and current Signed Contracts 44 Signed contracts between the facility and the external service provider defined the requirements for pest management activities for this facility Credentials and Competencies 45 Qualifications examined for selected IPM service providers were documented and current 18 of 23

19 Pesticide Documentation 46 Pesticide labels and chemical safety data sheets were provided for the pesticides randomly examined during the inspection Pesticide Application Documentation 47 Pesticide application documentation was current and provided records to identify, document, and verify use of pesticides randomly examined during the inspection Trend Analysis 49 Service records of monitoring devices and pest sightings reviewed appeared to be used to identify and eliminate areas of pest activity as noted by the lack of significant activity observed during the inspection Monitoring Device Documentation 410 Monitoring devices were mapped and maintained to ensure proper placement and monitoring for pest activity and trending The map appeared to be current based on observation during the inspection Exterior Rodent Monitoring Devices 411 Exterior rodent control devices were placed and those randomly reviewed were maintained to provide rodent monitoring and to deter entry into the facility Interior Rodent Monitoring Devices 412 Interior rodent monitoring devices were placed and those randomly reviewed were maintained to identify and capture rodents that have gained access to the facility Insect Light Traps 413 Insect light traps were provided and those reviewed were maintained to identify and monitor flying insects in the facility Bird Control 415 Bird control activities were addressed and the lack of activity noted during the inspection indicated that the program was effective Wildlife Control 416 No issues with identification or elimination of wildlife habitat were noted Pest Habitat 417 No evidence of rodent, bird, insect, or other pest issues were identified during the inspection Written Policy 51 A written policy emphasizing the facility's commitment to provide safe and legal food products was documented for this facility Accountability 52 Management authorization and support of supervisory compliance to programs, laws, and regulations was defined for this site and appeared to be implemented Support 53 Human and financial resources were provided to support implementation of the Food Safety and Prerequisite Programs Written Procedures 54 Written procedures randomly reviewed for food safety activities at the facility defined owners, actions, and timelines Written Procedure Audits 57 Written procedure audits were documented to validate the appropriateness and implementation of procedures defined for this site Records randomly reviewed indicated that audits were conducted and current Customer Complaint Program 58 A Customer Complaint Program was implemented to respond to customer concerns Protocols were in place to ensure that food safety issues were responded to in a prompt and effective manner, whether it be at the facility level or as managed by corporate 19 of 23

20 Chemical Control Program 59 A documented Chemical Control Program was implemented to provide a centralized approach to manage and control purchase and use of nonfood chemicals Random review of chemicals and program requirements indicated that this program had been implemented as applicable for this facility Allergen Control Program 511 Allergen controls were implemented to identify allergen control throughout the process from receiving to distribution of product Random review of the program, records, and observations during the inspection indicated that the program was implemented Glass, Brittle Plastics, and Ceramics Program 512 A documented Glass, Brittle Plastics, and Ceramics Program was provided to identify processes that prevent contamination of product There were no identified deficiencies noted during the inspection to indicate that the program was ineffective Cleaning Program 513 A Cleaning Program with schedules and procedures for accomplishing cleaning tasks critical to maintenance of the food processing environment was documented Random review of schedules and cleaning procedures, in addition to observations, indicated that the program appeared to be effective Receiving Program 515 The Receiving Program implemented at the facility outlined and identified requirements for the raw materials received at this site Random review of the program and documentation of receipt of materials indicated that materials receipts were consistent with the defined program requirements Regulatory Affairs and Inspection Program 516 A documented Regulatory Affairs and Inspections Program provided instructions for handling of regulatory, third party, and customer inspections Traceability Program 518 The written Traceability Program defined the methodology to allow quick location of suspect raw materials, food contact packaging materials, rework, and related finished products Recall-Withdrawal Program 519 The written Recall/Withdrawal Program documented the procedures for quick and controlled recovery of product from the market Random review of the records and mock recovery exercises indicated that the program was implemented as defined for this facility Nonconforming Product Program 520 The Nonconforming Products Program defined the guidelines for isolation, investigation, and disposition of raw materials, packaging materials, work-in-progress, returned goods, and finished products as applicable to the facility Random review of records and observations during the inspection did not identify any current deficiencies with this program Approved Supplier Program 521 Evaluation of goods and services that impact the facility's food safety programs were managed as part of the Approved Supplier Program Materials randomly selected and reviewed during the inspection appeared to meet program requirements Specification Program 522 Specifications that defined food safety requirements for raw materials, food contact packaging materials, processing aids, work-in-progress, and finished products were maintained, as applicable to this facility Random review of materials indicated that facility defined program requirements were currently being met 20 of 23

21 Letters of Guarantee or Certifications 523 Statements of assurance in the form of letters of guarantee or certifications were provided to indicate compliance to regulatory requirements for received materials and finished products Records randomly reviewed indicated that the facility was currently meeting their program requirements HACCP Program 525 A HACCP Plan that evaluated the hazards associated with the raw materials and processes related to product or food category was defined and implemented for the facility This included the hazard analysis and identification of critical control points, as applicable, to prevent, eliminate, or reduce these hazards to an acceptable level Random review of records indicated that the facility met the CCPs requirements or that appropriate deviation procedures were implemented as identified by the program Release Procedures 527 Release procedures as defined for this facility were implemented to ensure that materials were checked for food safety hazards prior to release and shipment to the customer Design Standards 528 Structural and equipment design standards were implemented to aid in maintenance of food safety programs Water Quality 529 Water, water sources, and water management strategies were implemented to ensure safe water for product contact and use Random reviews of the records indicated that programs were implemented 21 of 23

22 Standards Not Applicable Standard # Standard Name 17 Designated Rework Areas 18 Dust Collection and Filtering Devices 19 Bulk Material Handling 111 Processing Aids 113 Bulk Material Sifting 114 Bulk Liquid Materials 117 Ingredient Scoops 120 Single-Service Containers 122 Temperature-Sensitive Materials 124 Containers and Utensils 125 Cans, Bottles, and Rigid Packaging 131 High-Risk Clothing Management 138 Examination of Materials 26 Drains 217 Temperature Measuring Devices 222 Bulk Systems and Unloading Areas 223 Ammonia Control 224 Wastewater Treatment and Sewage Disposal 37 Clean in Place (CIP) Systems 43 Other Guidelines 48 Pesticide Control 414 Pheromone Monitoring Devices 510 Microbial Control Program 524 High-Risk Processing Record Program 526 Specialized Testing 22 of 23

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