Microbiology FDA 483 (Boothwyn Pharmacy): Use of a sporicidal agent in the facility’s ISO 5 areas and classified areas was improper

Observation

Use of a sporicidal agent in the facility’s ISO 5 areas and classified areas was improper

Facility Type

Sterile Manufacturing

Firm / Company

Boothwyn Pharmacy LLC

System

Quality System, Laboratory Controls, Facility and Equipment System

Details

Specifically,

(A) On August 18, 2023, your technician *** did not clean the ***, located *** the ISO 8 classified preparation room *** and the ISO 7 classified buffer room ***, with a sporicidal agent, or any cleaning agent, during direct observation of the *** cleaning of the sterile suite containing the LAFW.

(B) On August 18, 2023, your technician *** was observed to be inconsistently cleaning the walls of the ISO 7 and ISO8 classified rooms as parts of the walls showed no evidence of wetness during the *** cleaning of rooms *** – ***.

Record Date

03/2024

FEI Number

1000076625

Country

Pennsylvania

Citation Type

483

Audit Duration (Days)

8

Investigators

Christina K Theodorou

More observations from same firm / company

Microbiology FDA 483 (Boothwyn Pharmacy): Smoke studies were inadequately performed under dynamic conditions

Microbiology FDA 483 (Boothwyn Pharmacy): Influx of lesser quality air into a classified area containing higher quality air

Microbiology FDA 483 (Boothwyn Pharmacy): Use of non-sterile cleaning wipes in the ISO 5 area

Microbiology FDA 483 (Boothwyn Pharmacy): Inadequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination

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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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