Microbiology FDA 483 : Equipment and utensils are not cleaned and maintained

Observation

Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions, contamination, that would alter the safety, identity, strength, quality or purity of the drug product.

Facility Type

Non-Sterile Manufacturing

Firm / Company

Torrent Pharmaceuticals Limited

System

Facilities And Equipment System

Details

You have not performed a cleaning validation for the glassware washer (Smeg Model #GW3060S, ID #T****) located in the Microbiology Lab and verified the effectiveness of the manual cleaning of glassware that cannot fit into the glassware washer to ensure they are cleaned. In addition, SOP #***(Operation and Cleaning of Glassware Washing Machine) does not state the cleaning agents to be utilized for the glassware washing machine.

Record Date

12/2023

FEI Number

3012740315

Country

India

Citation Type

483

Audit Duration (Days)

5

Investigators

Yvins Dezan

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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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Microbiology FDA 483 (Precision Equine LLC): Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination
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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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