Microbiology FDA 483 (Empower Clinic Services) : Aseptic manipulations where the movement of first air in the ISO 5 area is blocked or disrupted

Observation

Personnel were observed conducting aseptic manipulations where the movement of “first air” in the ISO 5 area is blocked or disrupted.

Facility Type

Sterile & Non-Sterile Manufacturing

Firm / Company

Empower Clinic Services LCC dba Empower Pharmacy

System

Quality System, Facility and Equipment System

Details

Specifically, on 11/13/2023, during a review of selected *** aseptically sterile lots that were produced within your firm’s Formulation Room *** designated ISO 5 LAFUs (Asset IDs E4252 & E4689), the following poor aseptic techniques were observed *** :

(A) During the aseptic production of Lipo (M/C) 30ml, processed on 10/31/2023, Lot.186***, BUD 04/24/2024, we observed the following deficiencies within your firm’s ISO 5 LAFU *** Asset ID E4252):

  1. Sterile compounding technician was observed reaching over open finished drug filled vials while filling empty vials.
  2. Your firm’s sterile compounding technician was observed dumping aluminum caps from *** bag overtop rubber stoppered vials and placing the caps on top of the stoppered vials while the *** sterile compounding technician filled empty sterile vials.

(B) During the aseptic production of Lipo (M/C) 30ml, processed on 10/31/2023,.Lot 186017, BUD 0d/24/2024, we observed the following deficiencies within your firm’s Formulation Rooms *** LAFU *** (Asset ID E4689):

  1. Your firm’s sterile compounding technician was observed obstructing first air by placing a large open bag of *** rubber stoppers and metal caps in front of an un- stoppered tray of filled sterile vials.
  2. Your firm’s sterile compounding technician was observed obstructing first air by placing mi open bag of sterile rubber stoppers and aluminum caps in front of a tray of open sterile

(C) During the aseptic production of Bi-Amino Injection (30ml) 100/100 ml, Lot 187369, BUD 04/28/2024, we observed the following deficiencies within your firm’s ISO 5 LAFU *** Asset ID E4252):

  1. Your firm’s sterile compounding technician was observed reaching over open exposed finished sterile drug vials while *** aseptically filling empty sterile vials.
  2. During aseptic filling of sterile vials by your firm’s sterile compounding technician, we observed large open bags of stoppers, aluminum caps in front the tray of open filled sterile drug vials, and a hanging bottle of *** disrupting airflow and first air during aseptic filling.
  3. Compounding technician observed un-stoppered tray of vials filled with finished sterile drug product first air being blocked by an open large bag of *** rubber stoppers and metal caps within ISO 5 LAFU.

Record Date

02/2024

FEI Number

3021758709

Country

Texas

Citation Type

483

Audit Duration (Days)

19

Investigators

Camerson E Moore, Demario L Walls

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FDA 483 relevant to Microbiology

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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Your container closure integrity test for *** Injection (USP) ***mg/***ml is inadequate, The test used empty vials instead of fille vials. Microbial Challenge Study was conducted without a positive control. Dye ingress study was conducted using human eye detection with results "not detected" without specifying the limit of detection,

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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 ***.

Microbiology FDA 483 (Jubilant Radiopharmacies): The movement of first air in the ISO 5 area is blocked or disrupted

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Microbiology FDA 483 (Eugia Pharma Specialities): Aseptic processing areas are deficient regarding the system for monitoring environmental conditions

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On April 29, 2024, *** cleaning wipes packed and ready to be used for *** aseptic cleaning in the Grade A area of the *** Injection *** filling line *** had loose threads and fibers them. The same wipes are also used for *** cleaning in the *** Injection manufacturing line ***. Upon receiving, the wipes are not inspected for the presence of loose threads and fibers.
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