is used for cleaning and disinfecting the core sterile injectable

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1 - OS 21/2013* Inc. 2 Walnut Gr ove Dr Suite Horsham PA Prod ucer o f Sterile Pro d ucts This document lists ol>servations made by the FDArepresentative(s) during the inspection ofyoorfilcility. They are inspectional observations, and do not represent afinal Agency determination regarding your compliance. Ifyoo have an objection regarding an observation. or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA repreaentative(s) during the inspection or submit this information to FDA at the address above. Jfyou have any questions, please contact FDA at the phone number and address above. DURING AN INSPECTION OF YOUR FIRM I OBSERVED: OBSERVATION 1 Buildings used in the manufacture, processing, packing. or holding of a drug produ<..'t do not have the suitable size, construction, andlocation to facilitate cleaning, maintenance, and proper operations. L Plastic flap dividers with large gaps between each flap are utilized. to separate the warehouse area from the anteroom. Plastic flap dividers with large gaps are also utilized to separate the anteroom from the clean room which houses all ISO 5 Laminar Flow Hoods and the biological safety cabinet. 2 Buckets used for cleaning were observed directly next to, and adjacent to both sides ofthe plastic flap divider. This plastic flap divider is used to separate the anteroom from the clean room thai houses all ISO 5 Laminar Flow Hood..;; (LFH) and the Biological Safety Cabinet. 2. There is no designated area for personnel responsible for processing sterile injectable drugs to gown into masks, shoe covers, caps,,gloves and gowns prior to entering the clean room where the ISO 5 Laminar Flow Hoods are located. 3. Warehouse employees were observed moving from the warehouse area into the anteroom which is adjacent to the clean room in an uncontrolled manner. Warehouse personnel were observed coming in contact with components that were staged to enter the clean room, where the ISO 5 Laminar Flow Hoods are located. OBSERVATION 2 The control. systems necessary to prevent contamination or mix-ups are deficient. is used for cleaning and disinfecting the core sterile injectable 05/21 /201 3

2 DEPARTMENTOF HEALTHAND HUMANSERVICES FOOD AND DRUG ADMlNISTR.'I.TION OS Customhouse, Rm 900 2nd & Chestnut St 05/01/ * Philadelphia, PA (215) Fax: (215) Industry Information: TO: David M. Tomasello, Chief Operating Officer Home Inf usions Solut ions, Inc. CITY, SfA"lE. ZIPCOD!:. COUNTRI' Horsham, PA Producer of Sterile Drug Products..,.~:u.,l.ll~ studies were performed to assure the suitability and effectiveness ofthe used for spore, fungi and bacterial removal. Also, no recovery pertorrned to assure is effective. is used for cleaning and disinfecting the clean room, ISO 5 Laminar Flow Hoods and Biological Safety Cabinet. 2. No viable air samples for fungi or bacteria were taken dmingthe-qualification conducted in September 2012 tor any ofthe ISO 5 Laminar Flow Hoods (LFH.s P2, P6, and P7) or the Biological Safety Cabinet (P4). AdditionallY,, durillg qualifications performed in September2012 and April 2013 no surface samples for bacteriaor were obtained for the critical areas inside the ISO 5 Laminar Flow Hoods {LFHs P2, P6 and P7), Biological Safety Cabinet (P4), critical contact areas, or equipment located in the ISO 5 areas. time JJ IRB BF CM DS SP DP the manufacture instructions require that the Also, there are no records avru.1able describing what type can support OBSERVATION 3 Procedures designed toprevent microbiological contamiriation ofdrug products purporting to be sterile are not established. 1. Per SOP (titled Process Simulation Testing) as part ofthe media fill tests, process simulating EMPLOVEE(S) SIGI>IATURE Oli /? SEE REVERSE Anita R. Michael, Investigator 1 /. I ( t"v(_ INSPECTIONAL OBSERVATIONS OATEisstED 05/21/201 3 PAGE20FSPAG!i!S

3 DEPARTMENT OF HEALTil AND HUMAN SERVICES FOOD AND DRUG ADMINlSl'RATION OS CUs tomhouse, Rm 900 2nd & Chestnut St 05/0 1/ /21/201 3 * FEl-BER ~ PhiladelPhia, PA (215) Fax: (215) Industry Information: TO: David M. Tomasello, Chief Operating Officer Home Infusions Solutions, Inc. CITY, STAlE, ZIP CCOE, COUtll'RY Horsham, PA Producer of Sterile Drug Products testing must be completed to assure em1t>imrees Pr<>CeJ>Silltg qualified to perform ase:oti.c process;mg. SOP the For tests. was incubated was not documented for all tests listed below. Also, test dates were missing (arrows used) and sample numbers were missing for all samples listed below. Additionally, media lots numbers were not documented as listed below: Media Test BF LITSB Media Test RN LffSB Media Test SP LffSB Media TestDS UfSB Media Test TH UISB Media Test DP L!TSB Media Test IRB UfSB Media Test CB UfSB no media lot number documented Media Test JJ UTSB no media lot number d.ocumenetd Media Test CM UfSB no media lot number documented the manufacture instructions require that the There is no data to support the Also, there are no records available describing what type of bacteria, yeast, mold and ftmgi - can support. 2. A computer screen was observed inside the ISO 5 Laminar Flow Hood (LFH P2} adjacent to where sterile injectable drugs are processed. This screen was located in front ofthe HEP A filter that provides unidirectional air flow into the core ISO 5 LFH P2. There are no cleaning studies orprocedures addressing how the computer screen wo~ld be sanitized, disinfected and routinely cleaned. 3. A radio was located within the clean room that houses the I ISO 5 Laminar Flow Hoods and I Bio Safety Cabinet. This radio was located near the ISO 5 LaminBr Flow Hood (LFH P7). 'b SEE REVERSE Anita R. }ti.chael, Investigator INSPECTIONAL OBSERVATIONS DATEISSUED PMJI!J OF 5 PAGI?.S

4 DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINIS'IRA~ DISTRICT ADDRESS AND I'HONI';;;IIUioilleR US Customhouse, Rm 900 2nd & Chestnut St PhiladelPhia, PA (215) Fax : ( 215) Industry Information: www. fda. gov/oc/industry NAME AKJ IIIli=. OF INDMOUALTOWHON t<=>'uki ISSUBl TO: David M. Toma s ello, Chief Oper ating Officer F IRM NAtJE Home Infusions Solutions, Inc. CITY. STA'I:, ZPCODE. COVIliRV Horsham, PA DATI:($} OfIHSf'WTICi'l 05/01/ * FaNU!EER S1'Rarr ADilR5SS Suite HO TY1'E.ESTABI.ISH>IEMT INSI'ECTI:D Producer of Sterile Drug Products OBSERVATION 4 There is no written testing program designed to assess the stability cbaract..,"'istics of drug products. 1. Currently, the assigned before use date (BUD) is 7 days at refrigerated conditions for Invanz (Ertapenem)) 1 GM/m4 pri.-nary packaged in the Eclipse pump. For Invanz there are no stability samples tested to support the 7 day BUD. 2. Records reviewed from 02/2012 through 09/2012 the assigned befor~ use date (BUD) was 28 days at refrigerated conditions for Vancomycin} GM/ml, primary packaged in the Eclipse pump. For Vancomycin there are no stability samples tested to support the 28 day BUD. 3. For records reviewed for the month of02/2012 the assigned before use date (BUD) was 28 days for Morphine at multiple concentrations. For Morphine there are no stability samples tested to support the 28dayBUD. 4. Forrecords reviewed for the month of02/2012 the assigned before use date (BUD) was 28 days for Hydromorphone at multiple concentrations. For Hydromorphone there are no stability samples tested to support the 28 day BUD. OBSERVATION 5 Protective apparel is not worn as necessacy to protect drug products from contamination. < personnel responsible for processing sterile injectable drugs within the ISO 5 Laminar Flow Hoods were not gowned in sterile gowning. For example the mas~ shoe covers, caps and gowns were not sterile. "' DATES OF INSPECTION: 05/0l/20 13(Wed), 05/ (Thu), 05/03/2013(Fri), 05/06J20l3(Mon), 05/ (Tue), 05/08120l3(Wed), 05/09/2013(Thu), 05/21/20 13{Tue) SEE REVERSE OFTHts PAGE EMPI..O'I'BC(S) SlGNAl'\JRE Anita R. Michael, Investigator ak_ jj_ DATE ISSUED FORMJ!l)A 4.> (~Ita) nevious El>l'l'JO)'I OBSOl.EIE INSPECflONAL OBSERVAnONS J>AOE 4 OF Sl'AGES

5 DEPARTMEl''T OF HEALTH AND HUM.Iu~ SERVICES FOOD A.)ID DRUG ADMINISTRATION US Customhouse, Rm 900 2nd & Chestnut St 05/01/ * Philadelphia, PA (215) Fax: (21 5) Industry Information: _,_, TO: David M. Tomasello, Home Infusions Solutions, Chief Operating Inc. Of ficer S"IREErAOORESS Horsham, PA Producer of Steril e Drug Products { O,O.TE ISSUED Anita R. Michael, SEE REVERSE Invest igator~~~- INSPECTIONALOBSERVATIONSc- PAGE50F5PAGES