Microbiology FDA 483 (Barclay, Luke & Pillai Specialty Pharmacy): Aseptic processing areas had visibly dirty equipment or surface

Observation

The ISO 5 classified aseptic processing areas had difficult to clean and visibly dirty equipment or surface.

Facility Type

Sterile & Non-Sterile Manufacturing

Firm / Company

Barclay, Luke & Pillai Specialty Pharmacy, PLLC

System

Quality System, Facility and Equipment System, Laboratory System

Details

Specifically,

The ISO 5 hoods in your sterile non-hazardous cleanroom, both of which are used to produce drug products purported to be sterile, were observed to contain visibly dirty surfaces during multiple walkthroughs between 11/28/22 and 12/02/22. Those observations include, but are not limited to the following:

(a) An accumulation of a fibrous material around the edges of the holes along the work surface front edge, work surface back edge, and side walls of the *** hood.

(b) An equipment ID sticker stuck to the left wall of the ISO 5 workspace inside the *** hood, with visible discoloration underneath the laminate covering the sticker.

(c) Seven red-brown apparent splatter marks on the surface of the *** HEPA filter inside the back wall of the ISO 5 *** laminar flow hood (LFH).

(d) An approximate 8″ vertical crack in the right side of the plastic sash of the *** hood.

On 11/29/22, the *** hood was observed to be used in the production of 100 mL of Niacinamide 100 mg/mL lllJectab1e solution, lot ***.

Record Date

02/2024

FEI Number

3011888866

Country

Nevada

Citation Type

483

Audit Duration (Days)

9

Investigators

Christopher R Czajka

More observations from same firm / company

Microbiology FDA 483 (Barclay, Luke & Pillai Specialty Pharmacy): Non microbial contamination was observed in your production area

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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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