Microbiology FDA 483 (Dr. Reddy’s Laboratories): Appropriate written specifications for acceptance are deficient

Observation

Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products

Facility Type

Non-Sterile Manufacturing

Firm / Company

Dr. Reddy's Laboratories Ltd.

System

Quality System, Laboratory Controls, Facility and Equipment System

Details

Specifically, determination of conformance to written specifications are deficient for TAMC (Total Aerobic Microbial Count) test and TYMC (Total Yeast and Mold Count) test conducted for purified water and drug products.

On 10/19/2023, the colony counter (equipment ID: QCE 739) in micro lab was observed missing the colony counts when the analyst was reading the plates and reviewer was verifying the counted colonies for ** samples collected on 10/14/2023. For example:

(A) The colony counter did not count every colony for multiple samples including LINIS sample #*** (location: ***) when micro lab analyst *** pressed the media plate placed on the colony counter (QCE 739) with *** pen.

(B) The colony counter did not count every colony for multiple samples including LIMS sample # *** (Location ***) when micro lab reviewer *** performed the verification of the colonies counted by analyst ***. During the verification pressed the media plate placed on the colony counter (QCE 739) with *** pen. For this sample, the colony counter failed to count the colony even when the reviewer pressed the plate with such a force that the tip of *** pen broke.

Record Date

10/2023

FEI Number

3002949099

Country

India

Citation Type

483

Audit Duration (Days)

6

Investigators

Saleem A Akhtar, Pratik S Upadhyay

More observations from same firm / company

Microbiology FDA 483 (Dr. Reddy’s Laboratories): Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination

Microbiology FDA 483 (Dr. Reddy’s Laboratories): Failed to establish and/or follow adequate written gowning procedures

Microbiology FDA 483 (Dr. Reddy’s Laboratories): The accuracy, sensitivity, specificity and reproducibility of test methods have not been established

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

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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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