Microbiology FDA 483 (Eugia Steriles): Control procedures are not established which validate the performance of those manufacturing processes

Observation

Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug Product

Facility Type

Sterile Manufacturing

Firm / Company

Eugia Steriles Private Limited

System

Quality System, Laboratory Controls, Facility and Equipment System

Details

Specifically,

on 4/3/24 1 observed the manual visual inspection process of *** USP ***% batch *** for approximately *** during this time observed all *** operators observe vials that appeared to have white visible particles and classify them as good vials. During this time I also observed that during manual visual inspection the vials remained *** after the *** sterilization process, however there is no evaluation on how the presence of *** on the outer surface of vials affects the performance of visual inspection for defects. On 4/5/23 at approximately 11:30 AM observed again the visual inspection process and noted that one operator classified a vial with visible white particles as a good vial. I also requested employees to examine the vials from visual inspection qualification kit ID1 and two of the *** employees performing visual inspection failed to detect the white particles defect from the test kit.

Record Date

04/2024

FEI Number

3027357163

Country

India

Citation Type

483

Audit Duration (Days)

7

Investigators

Teresa I Navas

More observations from same firm / company

Microbiology FDA 483 (Eugia Steriles): Procedures to prevent microbiological contamination are not established and followed

Microbiology FDA 483 (Eugia Steriles): Input to and output from the computer and records or data are not checked for accuracy

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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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