Microbiology FDA 483 (Kilitch Healthcare): Buildings used in the manufacture of drug products are not maintained in a clean and sanitary condition

Observation

Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition

Facility Type

Sterile Manufacturing

Firm / Company

Kilitch Healthcare India Limited

System

Facility and Equipment System, Quality System

Details

Specifically,

(1) On October 13, 2023 it was observed during a production area walkthrough that the *** floor in the Grade B corridor outside of filling line *** had cracks and was not sealed to the wall.

 

(2) On October 17, 2023, during a walkthrough of the manufacturing and *** *** area, it was observed that the air vents in the employee changing room to enter the production areas had a buildup of dust on them.

 

(3) on October 13, 2023, *** use point *** in the equipment cleaning area was leaking and had an attached hose that was submerged in a bucket of stagnant water.

 

(4) On October 13, 2023, *** use point *** had an attached hose with stagnant water in it.

 

(5) The *** *** room has a Grade A LAF booth with a sink and a drain below it. Review of video recordings from October 4, 2023, show a *** filling the LAF and the surrounding Grade C room that is used to transfer material into the Grade B filling area. Production personnel identified this *** as material escaping from the drain located under the LAF booth.

 

(6) The *** room used to sterilize components of the aseptic filling line in *** has a Grade A LAF with a sink for washing equipment parts where the water from the sink goes into a drainpipe below. Review of the video recording from October 4, 2023, shows a *** filling the LAF and the surrounding Grade C room where the *** is located and where material is transferred from the Grade C into the Grade B filling area. Production identified this *** as coming up from a drain line that runs under the floor from the *** and is used to drain both the *** and the Grade A LAF sink water. The Senior Production Manager explained that this may be due to a problem in the pipe running under the floor (crack, leaks, blockage) and will require extensive maintenance to fix. Currently the *** remains in use, engineering has made minor repairs to minimize the problem, but some *** continues to leak out from the discharge from the ***.

 

(7) During a walkthrough of the production area on October 19, 2023, it was noted that the ceiling in the main ** room, *** had water stains, cracks and paint peeling off the ceiling. The area surrounding the drain and the adjacent wall were also observed to have cracks and brown/black residue buildup. This is where one of the environmental monitoring settle plate stands resides and where product is removed from the ***.

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

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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

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