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

Observation

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed

Facility Type

Sterile Manufacturing

Firm / Company

Stokes Healthcare Inc.

System

Quality System, Laboratory Controls, Facility and Equipment System

Details

Specifically…

(A) Your firm has not conducted smoke studies nor media fills under dynamic conditions in rooms C704, and C706 where filling operations under aseptic conditions takes place for human and animal drug products. For example,

 

(1) Air visualization “smoke” study *** utilized by your firm to validate your aseptic manufacturing process revealed that your operators did not include *** containers and assembly of sterile filling equipment including necessary aseptic connections such as, but not limited to, the filling nozzle and related tubing.

(2) Media fill protocol PR-23-0001 does not include all aspects of aseptic processing such as, but not limited to:

(i) The aseptic filling of the *** and the Tacrolimus *** concentrate which is *** vessel

(ii) The mixing of the *** and Tacrolimus *** concentrate using *** for the entire duration of aseptic processing, which is aseptically added to the *** vessel during this process

(iii) The use of *** to protect your *** media bottles *** to the ***, and then *** 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 *** *** ***.

 

(B) On 06/01/2023, firm personnel conducted *** for the human and animal drug product Fluorouracil 2500mg/50mL lot *** exp 12/16/2023, which is intended to be sterile. According to batch record Fluorouracil PF 50 mg/ml Injection Solution, the product was not aseptically filled that same day, nor was the *** conducted again after aseptic filling operations ceased. After the completion of the *** ***, the *** was placed into *** and ***. On *** was used to aseptically fill Fluorouracil lot ***. No *** was conducted after the batch was produced to ensure that the *** was not compromised after the ***. Your Director of Quality stated on 10/04/2023 that your firm does not perform *** of *** after production of the human and animal drug Fluorouracil PF.

 

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): Aseptic processing areas are deficient for cleaning and disinfecting to produce aseptic conditions

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

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

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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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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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