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

Observation

Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination

Facility Type

Sterile Manufacturing

Firm / Company

Boothwyn Pharmacy LLC

System

Quality System, Laboratory Controls, Facility and Equipment System

Details

Specifically,

(A) On August 9,2023 your technician (***) did not spray their gloves with a deactivating agent or change their gloves after measuring progesterone *** and then proceeded to touch other items, such as *** (lot ***) and *** (Lot ***), during the production of Progesterone 200mg/ml Cream (lot 08092023@***).

(B) On August 16, 2023, your technician (***) when donning their gowning before preparation operations of Medroxyprogesterone Acetate 200mg/mL lot 08162023@*** allowed the ties of their sterile smock to touch the ground in *** during gowning procedures. The ties were then wrapped around their waist, tying them at the front of their waist.

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

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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

Microbiology FDA 483 (Jiangsu Hengrui Pharmceuticals): Container closure systems do not provide adequate protection against foreseeable external factors

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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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Specifically, on 03/06/24, during the production of Gozetotide (Illucix) Cold Kit Lot# K-***, your firm's Pharmacy Manager was observed blocking first pass air in the ISO-5 *** flow hood. The following prescriptions were drawn from the cold kit and dispensed: RX*** (13.94 mCi) and RX*** (25.49 mCi).

Microbiology FDA 483 (Jubilant Radiopharmacies): Personnel were observed performing aseptic processing outside of an ISO 5 area

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Specifically, on 03/06/24, during the production of Gozetotide (Illucix) Cold Kit Lot# K-***, your firm's Pharmacy Manager was observed performing the following aseptic connections in the ISO-7 aseptic processing area: connecting the *** sterile *** to the Gallium Generator and connecting the Sterile *** to the Gallium Generator. The following prescriptions were drawn from the cold kit and dispensed: RX*** (13.94 mCi) and RX*** (25.49 mCi).

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

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Eugia Pharma Specialities Limited

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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