Microbiology FDA 483 (Eugia SEZ): Aseptic processing areas are deficient for cleaning and disinfecting

Observation

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions

Facility Type

Sterile Manufacturing

Firm / Company

Eugia SEZ Private Limited

System

Facility and Equipment System, Laboratory Controls, Quality System

Details

Specifically,

(A) There is no disinfectant efficacy study performed for *** tubing used for drug product transfer during vial filling on *** Line ***. The exterior of the *** tubing is not sterilized prior to installation in the filling assembly, located in the Grade A filling area, directly above *** and open vials during production operations.

 

(B) Your firm has no written procedure detailing the cleaning of *** step ladders, *** and *** Laminar Airflow Cabinet *** the Grade A and B (ISO 5/7) aseptic processing areas of your *** Injection Line and your *** Drug Lines. Additionally, no routine monitoring is performed for the *** of the various *** step ladders, and *** Laminar Airflow Cabinets, that *** aseptic processing areas, before and during production operations. A *** plate sample collected of the *** of the *** step ladder in your film’s *** production area on 02/23/24, sampled at the request of investigators, was observed to have microbial growth. *** monitoring locations do not include areas where these *** within the aseptic processing suites.

Record Date

03/2024

FEI Number

3011905047

Country

India

Citation Type

483

Audit Duration (Days)

9

Investigators

Ashar P Parikh, Marcellinus D Dordunoo

More observations from same firm / company

Microbiology FDA 483 (Eugia SEZ): Equipment is not suitably located to facilitate operations for its intended use

Microbiology FDA 483 (Eugia SEZ): Procedures designed to prevent microbiological contamination are not followed

Microbiology FDA 483 (Eugia SEZ): Procedures not followed for Enumeration of Microbial Colonies

Microbiology FDA 483 (Eugia SEZ): Written records are not always made of investigations into unexplained discrepancies

Microbiology FDA 483 (Eugia SEZ): Failure to maintain a backup file of data entered into the computer or related system

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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 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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