Microbiology FDA 483 (Stokes Healthcare): The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed

Observation

The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed

Facility Type

Sterile Manufacturing

Firm / Company

Stokes Healthcare Inc.

System

Quality System, Laboratory Controls, Facility and Equipment System

Details

Specifically, your quality unit did not follow its own procedure, POL-QA-1005 Quality Unit Policy which defines the responsibilities of all personnel involved in CGMP production operations at Epicur Pharma. For example;

 

(A) Your firm’s recent certification documentation: Clean Room Certification Report RM *** (Room C704), Cleanroom Certification Report RM *** (Room C706) and Cleanroom Certification Report RM *** (Room C709), where human and animal drug products intended to be sterile are manufactured, which was conducted in August 2023, shows that the HEPA filters located in the ceiling for your designated ISO5 areas in these rooms are higher than *** report. Each report was reviewed and signed off by both the contractor and your Director of Quality.

 

(B) Air visualization “smoke” study *** utilized by your firm to validate your aseptic manufacturing process revealed that your operators did not include *** operations in *** containers and assembly Of sterile filling equipment including necessary aseptic connections such as, but not limited to, the filling nozzle and related tubing. This video is reviewed and approved by the firm’s Microbiology Manager who is part of your firm’s quality unit.

 

(C) Per SOP POL-QA-1005 Quality Unit Policy, media fill protocols are approved by QA subject matter experts and are observed *** throughout the process and are simulations that are intended to represent routine operations and non-routine situations. Media fill protocol PR23-0001 does not include all aspects of aseptic processing such as, but not limited to, the aseptic filling of the *** and the Tacrolimus *** concentrate which is *** the *** during this process and the use of *** to protect your *** media bottles ***, and *** the ISO 5 classified aseptic processing area. In contrast, your master batch records indicate that you do not use *** to protect the Tacrolimus AQ drug concentrate and *** sterilization.

Record Date

03/2024

FEI Number

3002815949

Country

New Jersey

Citation Type

483

Audit Duration (Days)

12

Investigators

Christina K Theodorou, Yoriann M Cabrera Bartolomeir, Ruben C Quintana

More observations from same firm / company

Microbiology FDA 483 (Stokes Healthcare): Procedures to prevent microbiological contamination are not established, written and followed

Microbiology FDA 483 (Stokes Healthcare): Aseptic processing areas are deficient for cleaning and disinfecting to produce aseptic conditions

Microbiology FDA 483 (Stokes Healthcare): Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure

Microbiology FDA 483 (Stokes Healthcare): Aseptic processing areas are deficient regarding the system for monitoring environmental conditions

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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

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

Jiangsu Hengrui Pharmceuticals Co., Ltd

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,

Microbiology FDA 483 (Jiangsu Hengrui Pharmceuticals): Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process

Jiangsu Hengrui Pharmceuticals Co., Ltd

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

Jubilant DraxImage Radiopharmacies Inc.

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

Jubilant DraxImage Radiopharmacies Inc.

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

Eugia Pharma Specialities Limited

Surface monitoring of the filling and stoppering machine is not performed in a timely manner following the completion of aseptic filling operations to ensure the data is representative of the environmental conditions at the time of filling. For example:

Microbiology FDA 483 (Eugia Pharma Specialities): Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions

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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