Microbiology FDA 483 (Kilitch Healthcare) : Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures

Observation

Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity

Facility Type

Sterile Manufacturing

Firm / Company

Kilitch Healthcare India Limited

System

Laboratory Controls

Details

(1) Environmental monitoring and personnel monitoring data is not reliable because of the materials used to conduct tests.

(a) *** contact plates prepared in house did not have enough media to ensure the *** surface was above the rim all the way around the plate on 27 of *** plates observed on October 12, 2023. At the end of incubation, 8 of the *** plates showed desiccation of the media.

(b) Settle plates that had been exposed in the aseptic manufacturing were observed to have media that was desiccated and cracking.

(c) In house-prepared environmental monitoring media does not contain neutralizers. Spray disinfectants are used in the areas where monitoring occurs. On October 19, 2023, *** was sprayed directly over settle plates during the setup for batch ***.

 

(2) During sterility testing of sterile components by direct inoculation, the components were not observed to be completely submerged in the media.

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

Microbiology FDA 483 (Kilitch Healthcare): Buildings used in the manufacture of drug products are not maintained in a clean and sanitary condition

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

Microbiology FDA 483 (Kilitch Healthcare): Procedures designed to prevent microbiological contamination not include adequate validation of the aseptic process

Microbiology FDA 483 (Kilitch Healthcare): Laboratory records not complete and not assured compliance with SOP & Standards

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

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

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