Microbiology FDA 483 (Kilitch Healthcare): Aseptic processing areas are deficient for environment monitoring

Observation

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions

Facility Type

Sterile Manufacturing

Firm / Company

Kilitch Healthcare India Limited

System

Facility and Equipment System, Quality System, Laboratory Controls

Details

Environmental monitoring sampling locations have not been selected considering routine aseptic operations and interventions. Locations for surface monitoring that have not been considered include the *** used to perform interventions, the *** bowl, and the *** track.

 

Additionally, the sampling descriptions lack sufficient descriptions to ensure repeatable sampling. The swab sampling includes the location *** without describing which *** or where on the *** to sample. “Forceps” is a swab sampling point, but which of the multiple forceps needs to be sampled not specified or documented at the time of sampling.

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) : Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures

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

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

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

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

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): Established test procedures are not documented at the time of performance

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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 31 Aseptic Technique 50 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 10 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 3 Sterilization 3 Suitability 1 test procedure 0 Test Procedure (SOP) 10 Trends 1 Usage log 1 Validation 38 Visual Inspection 1 Warehouse 2 Water System 1
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