Microbiology FDA 483 (Empower Clinic Services) : Personnel infrequently changed and sanitized gloves to prevent contamination

Observation

Personnel infrequently changed and sanitized gloves to prevent contamination

Facility Type

Sterile & Non-Sterile Manufacturing

Firm / Company

Empower Clinic Services LCC dba Empower Pharmacy

System

Quality System, Facility and Equipment System

Details

Specifically, (A) On 10/23/2023, during observation of your firm’s automated vial filling operation within your firm’s ISO 5 Cleanroom, for the drug product, NAD+ (Nicotinamide Adenine Dinucleotide) (LYO) 500ing Injectable, Lot 186001, BUD 10/15/2024 within the firm’s ISO 5 Filling Room, we observed the firm’s sterile compounding technician enter, perform a designated task within the *** filling machine, and restart the ISO5 *** filling machine without disinfecting their gloves prior to returning to stacking the vials into the *** containers. Additionally, other technicians were observed entering the ISO 5 Classified production area, touching the entry door and proceeded to perform tasks within the room without disinfecting their gloves.

 

(B) Your trim’s sterile compounding technician failed to disinfect gloves after performing an activity on the *** table within &e ISO 7 area prior to returning to the ISO 5 LAFU *** (Asset ID E4252) to add sterile rubber stoppers and metal caps overtop of finished sterile drug filled vials during the aseptic production LIPO (M/C) 30 ml, Lot 186017 processed on 10/31/2023, BUD 04/27/2024.

 

(C) Your firms sterile compounding technician was observed using there sterile gloves to push down trash inside garbage bin a8er unwrapping rubber stoppers and metal caps from *** bag within ISO 5 LAFU *** (Asset ID E4252). Your firm’s sterile compounding technician failed to change sterile gloves before returning to aseptic filling operation. This action was observed twice during the aseptic production of LIPO (M/C) 30ml, Lot 186017, BUD 04/27/2024.

Record Date

02/2024

FEI Number

3021758709

Country

Texas

Citation Type

483

Audit Duration (Days)

19

Investigators

Camerson E Moore, Demario L Walls

More observations from same firm / company

http://pharmamicrobiology.com/fda-citation/microbiology-fda-483-empower-clinic-services-aseptic-manipulations-where-the-movement-of-first-air-in-the-iso-5-area-is-blocked-or-disrupted/

http://pharmamicrobiology.com/fda-citation/microbiology-fda-483-empower-clinic-services-failure-to-clean-and-disinfect-or-sterilize-equipment-located-in-the-iso-5-area/

 

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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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