Microbiology FDA 483 (Kilitch Healthcare): Aseptic processing areas are deficient for cleaning and disinfecting

Observation

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions

Facility Type

Sterile Manufacturing

Firm / Company

Kilitch Healthcare India Limited

System

Facility and Equipment System, Quality System

Details

(1) There is no assurance an effective sporicidal is used in the aseptic filling areas. *** *** is done with *** which is intended to be used as the only sporicidal inside the filling ***. No validation data of the *** process is available to show the is *** effective against spores or the *** process can penetrate all areas in the filling line.

 

(2) Disinfectant efficacy studies did not consider surfaces including ***, ***, ***, ***, or *** ***.

 

(3) Mops used in the filling room are not sterilized and were observed to be passed back and forth from the Grade C to the Grade B areas.

Record Date

11/2023

FEI Number

3011853060

Country

India

Citation Type

483

Audit Duration (Days)

7

Investigators

Anastasia M Shields, Justin A Boyd

More observations from same firm / company

http://pharmamicrobiology.com/fda-citation/microbiology-fda-483-kilitch-healthcare-laboratory-controls-do-not-include-the-establishment-of-scientifically-sound-and-appropriate-specifications-and-test-procedures/

http://pharmamicrobiology.com/fda-citation/microbiology-fda-483-kilitch-healthcare-procedures-are-not-established-written-and-followed-to-prevent-microbiological-contamination/

http://pharmamicrobiology.com/fda-citation/microbiology-fda-483-kilitch-healthcare-laboratory-records-not-complete-not-assured-compliance-with-sop-standards/

http://pharmamicrobiology.com/fda-citation/microbiology-fda-483-kilitch-healthcare-procedures-designed-to-prevent-microbiological-contamination-not-include-adequate-validation-of-the-aseptic-process/

 

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

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