DEPARTMENT OF HEALTH AND HUMAN SERVICES · do not include adequate validation of the sterilization...
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SLGNATIK SEE REVERSE Erika V But l er, Investigator ......... 8/28/2015 OF THIS PAGE Zachery L Miller , Investigator X ........ - FORM FDA 433 (119M) PIUMOI.IS EDI'l'ION 08SOU!tB INSPECfiONAL OBSERVATIONS PAGB I OF 5 PAGtiS DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION OISllOOf JJlOilj;$$ mo PHON; IM.IIIER 6th & Kipling St. (P.O. Box 25087) Denver , co 80225 -0087 (303)236-3000 Fax: (303)2 36- 310 0 8/24/2015-8/28/2015 FEIIiUiol8m 3011752429 NAME .AJ«> nn.E OF INIJIVliJUI\I. TU'Mi<lM R£1'0RT ISSUeO Wil liam o. Richardson , Chief Executive O fficer FIRM NAME Isomeric Pharmacy Solution, LLC STREET ADOReS& 2401 S Foothill Dr, Suite D cw , STATE, ZIP CODE. COOUTR'I' Salt Lake City, UT 84109-1 479 O uts ourcing Facility This documcn!lists observations made by the FDA rcpresentative(s) during the inspection of your facility. They are inspectional observations, and do nol represenl a fin al Agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objecti on or action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above. DURING AN INSPECTION OF YOUR FIRM WE OBSERVED: OBSERVATION 1 Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process. Specifically, A. Your fmn has not validated the terminal sterHization process of the moist heat autoclave to demonstrate a heat penetration of 121 degrees Celsius in the Triamcinolone Acetonide/Lidocaine HCL 40/10 mg/mL Injectable suspension drug vial. B. Your firm has not qualified the Tuttenaeur Autoclave (Equip #EQ-0013, Model #EZlO 2540EA, Serial #14120302) that was used to terminally sterilize compounded product Triamcinolone Acetonide/ Lidocaine HCL 40/10 mglmL Injectable Suspension, Lot Nwnber: 06302015@4, on June 30th, 2015. Specifically, your operational qualification did not include calibration of the autoclave's pressure and time parameters. In addition, a perfonnance qualification of simulated real world autoclave conditions has not been completed. C. Your firm's in situ air pattern analysis (smoke studies) was not conducted under dynamic conditions, simulating routine production (I.e. compounding equipment in place and operations ongoing). Without, there is no assurance critical processing areas are suitable for aseptic manufacturing of sterile drug products. The three current smoke study videos (for each of the three laminar flow hoods) were filmed on May 13th, 2015. OBSERVATION 2 Aseptic processing areas are deficient regariling the system for monitoring environmental conditions.
Transcript of DEPARTMENT OF HEALTH AND HUMAN SERVICES · do not include adequate validation of the sterilization...
EMPI.()~ SLGNATIK ~TE.lssveD
SEE REVERSE Erika V But l er, Investigator ......... 8/28/2015 OF THIS PAGE Zachery L Miller , Investigator X ~VMe' ........ -~l!J:fttoi'V. IW:t'.S
FORM FDA 433 (119M) PIUMOI.IS EDI'l'ION 08SOU!tB INSPECfiONAL OBSERVATIONS PAGB I OF 5 PAGtiS
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION
OISllOOf JJlOilj;$$ mo PHON; IM.IIIER
6th & Kipling St. (P.O. Box 25087) Denver , co 80225-0087 (303)236-3000 Fax: (303)236- 3100
~'IE(l»OI'
8/24/2015-8/28/2015 FEIIiUiol8m
3011752429
NAME .AJ«> nn.E OF INIJIVliJUI\I. TU'Mi<lM R£1'0RT ISSUeO
William o. Richardson , Chief Executive Officer FIRM NAME
Isomeric Pharmacy Solution, LLC STREET ADOReS&
2401 S Foothill Dr, Suite D cw , STATE, ZIP CODE. COOUTR'I'
Salt Lake City, UT 84109-1479 l't'f'I!ESTABUSHoiSfT~
Outsourcing Facility
This documcn!lists observations made by the FDA rcpresentative(s) during the inspection of your facility. They are inspectional observations, and do nol represenl a final Agency determination regarding your compliance. If you 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 representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above.
DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:
OBSERVATION 1 Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
Specifically, A. Your fmn has not validated the terminal sterHization process of the moist heat autoclave to demonstrate a heat penetration of 121 degrees Celsius in the Triamcinolone Acetonide/Lidocaine HCL 40/10 mg/mL Injectable suspension drug vial.
B. Your firm has not qualified the Tuttenaeur Autoclave (Equip #EQ-0013, Model #EZlO 2540EA, Serial #14120302) that was used to terminally sterilize compounded product Triamcinolone Acetonide/ Lidocaine HCL 40/10 mglmL Injectable Suspension, Lot Nwnber: 06302015@4, on June 30th, 2015. Specifically, your operational qualification did not include calibration of the autoclave's pressure and time parameters. In addition, a perfonnance qualification of simulated real world autoclave conditions has not been completed.
C. Your firm's in situ air pattern analysis (smoke studies) was not conducted under dynamic conditions, simulating routine production (I.e. compounding equipment in place and operations ongoing). Without, there is no assurance critical processing areas are suitable for aseptic manufacturing of sterile drug products. The three current smoke study videos (for each of the three laminar flow hoods) were filmed on May 13th, 2015.
OBSERVATION 2 Aseptic processing areas are deficient regariling the system for monitoring environmental conditions.
DEPARTMENT OF HEALTH AND I lUMAN SERVICES FOOD AND DRUO hDMINISl'RATION
04$TRJCT IJlORESS NID PHOI£ IAA4WR ~TE(S)Qf' IIISI'eCllON
6t h & Kipling St. (P.O. Box 25087 ) 8/24/2015-8 / 28 /2015 Denver , co 80225- 0087 FEIIM.ISER
(303) 236- 3000 Fax:(303)236- 3100 3011752429
/'WdE 1\ND mt.£ Of' INiliiiiOlW. TO v.\101.1 RfPORT ISSUEO
Wil l i am 0 . Ri char ds on , Chi e f Executive Of f i cer FUUIIIAME STREET AD00£W
Isome r i c Pharmac y Solution, LLC 2401 S Foothill Dr, Suite D CITY. $TATE, ZlP 0001:. COI.\'ITRY l'!l'£EST IUSf'EClCD
Sa l t Lake City, UT 84109-1479 Outsourcing Facility
EI.IPlOYEE(S) S!GWoi\JR£ DATE ISSUED
SEE REVERSE Er ika V But l e r, I nvestigator ......... 8/28/2015 OF THIS PAGE Zache r y L Mi l ler, I nvestigator X l'ri'l'.>VMe' -·--__.)y.Citial'. Nilr<f
FORM FDA 433 (0911)3) PRIM()US f.lllTIONOOSOI.Il11! INSPECTIONAL OBSERVATlONS PAOBZOF ~PAGES
Specifically, A. Your finn does not conduct viable and non-viable air sampling (environmental monitoring) in your ISO 5 laminar flow hoods during compounding operations. For example, viable and non-viable monitoring was not performed during the compounding of Triamcinolone Acetonide/Lidocahte HCL 40/lO mg/mL Injectable Suspension, Lot Number: 06302015@4.
B. There is no scientific justification or documentation for the sampling locations of the affixed active air particle counters located in the ISO 7 compounding suites. One particle counter is located on the wall behind the IS0-5 laminar flow hood away from the activity in the cleanroom. The other is located on the viewing glass wall approximately 10 feet away from the biological safety cabinet.
OBSERVATION 3 There is no written testing program designed to assess the stability characteristics of drug products.
Specifically, Your firm has not conducted a stability study to support the beyond use dating of 90 days for Triamcinolone Acetonide/Lidocaine HCL 40/lO mg/mL Injectable suspension drug.
OBSERVATION 4 Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory confo1mance to the fmal specifications prior to release.
Specifically, Your firm does not test the preservative content of Benzyl alcohol and sodium chloride utilized as preservatives in the formulation for Triamcinolone Acetonide/Lidocaine HCL 40/l 0 mg/mL suspension at time of release.
OBSERVATION 5
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMJNTSTRATION
6th & Kipling St. ( P. O. Box 25087) Denver, CO 80225-0087 (303)236-3000 Fax: (303)236-3100
HAM~! NiO lffiJ! OF INOiViOUAi lOv.Kll.l REPORT iSSiJEo
8/24/2015-8/28/2015 FEINUMBER
3011752429
'Vlilliam 0 . Richardson , Chief Executive Officer FlRUNAMO< STREET .AIJORfSS
Isomeric Pharmacy Solution, LLC 2401 S Foothill Dr, Suite D CIIY, STAlE, ZlPCOOE. COUNT11Y
Salt Lake City, UT 84109-1479 Outsourcing Facility
EMf>I.O..U(S) SIGHATUill!
SEE REVERSE Erika V Butler, Investigator OF THIS PAGE Zachery L Miller, Investigator
FORM FPA 433 (0910$) INSPECTJONAL OBSERVATIONS
DAlE ISSUED
- 8/28/2015
PAG.IlJ OF 5 PAOI!S
The labels of your outsourcing facility's dn1g products do not include information required by sections 503B(a)(l O)(A) and (B).
Specifically, the following infonnation is not found on your drug product labels:
• The statements, "This is a compounded drug'' and "Office Use Only."
Examples of drug product labels that do not contain this information:
o Triamcinolone Acetonide/Lidocaine HCI40/10 mg/mL Injectable Suspension Betamethasone Acetate/Betamethasone Sodium Phosphate 3/4 mglmL Injectable Suspension Cyanocobalamin/Methionine/lnositoJ/Choline Chloride 1/25/50/50 mglmL Injection
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• The statements, "This is a compounded drug" and "Not for Resale," storage and handling instructions, and the date the drug was compmmded.
Examples of drug product labels that do not contain this information:
o Progesterone Capsule E4M150 mg Cyclobenzaprine/Diclofenac/Gabapentin!Ketamine/Orphenadrine/ Tetracaine 2%/3%/10%/15%/5%/2% 40 GM Liothyronine/Levothyroxine 20 mcg/75 meg Capsules
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Furthermore, the foHowing infonnation is not found on the container labels for some drug products you produce:
DEPARTMENT OF IJEALTll AND lWMAN SERVICES FOOD AND DRUG ADMINlSTRA TION
6th & Kipling St. (P.O. Box 25087) Denver, CO 80225-0087 (303)236-3000 Fax: (303)236-3100
NAA!E AY;() 1TTU! Of' l!.tJMOUAl TO 'ISStA:O
8/24/2015-8/28/2015 FEWIMlEII
3011752429
William 0. Richardson , Chief Executive Officer
Isomeric Pharmacy Solution, LLC 2401 S Foothill Dr, Suite D CITY, SlATE. ZIP CODE. COUNTR'f lYPEEST-.-., , INSPEC'Ja)
Salt Lake City, UT 84109-1479 Outsourcing Facility ----~--------------~
The route of administration.
Examples of container labels that do not contain this information:
Triamcinolone Acetonide/Lidocaine HCl 40/10 mg/mL Injectable Suspension Betamethasone Acetate/Betamethasone Sodium Phosphate 3/4 mglmL Injectable Suspension Cyclobenzaprine/Diclofenac/Gabapentin/Ketamine/Orphenadrine/ Tetracaine 2%/3%/10%/15%/5%/2%40 GM
Information to facilitate adverse event reporting: www.fda.gov/medwatch and 1-800-FDA-1088.
Examples of container labels that do not contain tlus information:
Progesterone Capsule E4Ml50 mg Cyclobenzaprine/Diclofenac/Gabapentin/Ketamine/Orphenadrine/ Tetracaine 2%/3%/10%/15%/So/o/2% 40 GM Liothyronine!Levothyroxine 20 mcg/75 meg Capsules
X Zadlefy L Miller
8{1Sf11JIS
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Erika V Butler, Investigator Zachery L Miller, Investigator
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