Microbiology FDA 483 (Central Admixture Pharmacy): Procedures are not established, written and followed to prevent microbiological contamination

Observation

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed

Facility Type

Sterile Manufacturing

Firm / Company

Central Admixture Pharmacy Services Inc

System

Laboratory Controls, Quality Systems, Facility and Equipment Systems

Details

Specifically,

(A) Your ISO 5 aseptic operators failed to demonstrate adequate aseptic technique. For example:

  1. On July 11, 2023, two (2) of your aseptic operators repeatedly dragged the underside of their gowning sleeves along the inside surface of the ISO 5 hood during aseptic production of injection drug products. The underside of aseptic operator sleeves also regularly touched ISO 7 surfaces, such as operator body gowning and plastic containers holding production materials. Your aseptic operators did not disinfect the underside of gowning sleeves when moving from ISO 7 to ISO 5. Underside of gowning sleeves were not sampled for personnel bioburden monitoring. Your procedure, SOP-CAPS-4000614 Gowning, instructs tucking gowning sleeves into gloves “to minimize excess material hanging from the forearm.”
  2. During observation of aseptic production on July 10, 11, 18, 21, 28, 2023, your aseptic operators failed to move slowly and deliberately within the ISO 5 laminar flow hoods during aseptic production and within the ISO 7 cleanroom suite. Your procedure, SOP-CAPS-4000175 Aseptic Technique, instructs ***movement in clean room areas.

 

(B) On July 11, 2023, your aseptic operator performed incomplete disinfection for over 100 drug substance vials prior to *** in ISO 5 hood during aseptic production of *** 10 mcg/ml in NS, 250 ml bag, Exp. Oct 9, 2023. Specifically,

  1. Vial caps were not disinfected during materials transfer from ISO 7 to ISO 5. In ISO 7 vial caps were covered by the operator’s gloved hand when *** of vials were sprayed with disinfectant. In the ISO 5 hoods the operator did not disinfect vials caps prior to removing the caps from vials with disinfected gloves. After removing vials caps, the operator did not disinfect gloves before performing additional aseptic operations in the ISO 5. Your procedure, SOP-CAPS-4000720 Product and Material Introduction and Movement, instructs spraying each item thoroughly, coating all surfaces with disinfectant, before placing into ISO 5 areas.
  2. Puncture sites for vials were not uniformly coated when sprayed with disinfectant. The distribution of spray was inconsistent with some puncture sites left dry, some with droplets, and some with pooled disinfectant. The operator used *** to puncture all the vials, and then connected that same *** to the IV bag holding *** drug substance. Your procedure, SOP-CAPS-4000175 Aseptic Technique, states that after the removal of cap/cover “the exposed surface must be properly sanitized”.

Record Date

01/2024

FEI Number

3004378804

Country

California

Citation Type

483

Audit Duration (Days)

20

Investigators

Jolanna A Norton, Rachel C Stanton

More observations from same firm / company

Microbiology FDA 483 (Central Admixture Pharmacy): Failed to thoroughly investigate instances of microbiological contamination

Microbiology FDA 483 (Central Admixture Pharmacy): Not include the establishment of scientifically sound and appropriate specifications

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Disclaimer: The purpose of this article is to provide helpful information on FDA 483s related to microbiological issues. This article represents 483 information in Tabular form for quick access and easy navigation. Information for this article is derived from “Form FDA 483” (Inspectional Observation). This article is not intended to replace the information provided by the FDA, nor is it guaranteed to be complete, always refer official FDA site for details.

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Alarm 1 Aseptic Behavior 30 Aseptic Technique 49 Autoclave 1 Biological Indicator 1 Building Maintenance 6 Calibration 1 Clean Room 15 Clean Room Practices 36 Cleaning and Sanitization 29 Cleaning Validation 1 Computerized System 4 Contamination 13 Contemporaneous Verification 1 Data Integrity Issue 10 Disinfectant Efficacy 2 Disinfection 15 Drug Product 1 Endotoxin 1 Environment monitoring 16 Equipment Cleaning 6 Equipment Operation 13 Facilities And Equipment System 13 Facility Design 5 Follow-Up Findings 2 General Cleaning 3 Good documentation Practices 4 Gowning 3 HEPA 4 Hold Time Study 2 HVAC 6 Influx of lesser quality air 1 Investigation 12 Investigation inadequate 5 Investigation incomplete 3 Laboratory Controls 17 Laboratory Practice 16 Maintenance 10 Manufacturing control 9 Media Fill 15 Method Transfer 2 Method Validation 5 Microbial Identification 1 Microbiological Contaminationn 10 No Procedure followed 14 Non-Conformance 1 OOS 5 Personnel Monitoring 3 Procedure 32 Qualification 32 Quality System 33 Risk assessment 6 Service Vendor Audit 1 Smoke studies 14 Specifications 5 Stability Study 2 Sterile Drug Products 5 Sterility Testing 1 sterilizati 2 Sterilization 3 Suitability 1 test procedure 0 Test Procedure (SOP) 10 Trends 1 Usage log 1 Validation 37 Visual Inspection 1 Warehouse 2 Water System 1

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Product contact equipment including *** stopper drums, *** were sterilized without outer wrapping and transferred from Grade A cart to Inside of the RABS without cover in Workshop *** Filling Room ***.

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