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

Observation

Non-microbial contamination was observed in your production area

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,

Your sterile non-hazardous and sterile hazardous cleanrooms, both of which are used to produce drug products purported to be sterile, were observed to contain several difficult to clean, particle generating, or 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) Apparent rust on multiple metal surfaces in the sterile non-hazardous cleanroom, including wheel casters supporting the *** °C refrigerator in the southwest comer of the room, wheel casters on a metal cart supporting a *** positioned adjacent to the *** °C refrigerator, metal hinges on a *** and a bolt in the right side of the *** hood outer casing.

(b) Apparent rust on multiple metal surfaces in the sterile hazardous cleanroom, including the metal tabletop used to support the *** machine, the metal support legs of the *** biosafety cabinet (BSC), screwheads inside the *** leading to the non-sterile hazardous cleanroom, the top of the right rear BSC support leg, and the feet on a metal stool positioned under the BSC.

(c) Uncovered sprinkler heads in the ceilings of both the sterile non-hazardous and sterile hazardous cleanrooms.

(d) Apparent cleaning chemical residue on multiple window walls in both the sterile non-hazardous and sterile hazardous cleanrooms, as well as on the hood sashes of the BSC in the sterile hazardous cleanroom and the *** hood in the sterile non-hazardous cleanroom.

(e) An instruction sheet titled “*** Processes and Procedures for Utilizing Clean Hoods” taped along all four sides to the ** hood in the sterile non-hazardous cleanroom with several raised and bubbled areas along each side of the tape.

(f) Black tape applied along all four edges of a window between the sterile hazardous cleanroom and the unclassified area in its frame, with the adhesive exposed along all four edges inside the sterile hazardous cleanroom.

(g) A metal exhaust pipe installed between the outlet of the BSC and the ceiling of the sterile hazardous cleanroom with raised and bubbled foil tape wrapped around the outside.

(h) Sections of damaged wall and gouged floor in the southwestern comer of the sterile non-hazardous cleanroom.

(i) An approximate 6″ crack along the west edge of a light box cover in the ceiling of the sterile hazardous cleanroom.

( j) Three consumer-grade air filters with exposed fabric and cardboard installed on top of the LFH in the sterile non-hazardous cleanroom.

(k) A damaged label on the *** laminar flow hood (LFH) in the sterile non-hazardous cleanroom, with material flaking off on the right side of the label.

(l) Exposed wood on the *** connecting sterile cleanrooms to adjacent spaces.

(m) A metal cart stored in the sterile hazardous cleanroom with several long scratches in its top surface.

(n) Soiled lower surfaces on two carts stored along the west side of the sterile hazardous cleanroom, and on the bottom shelf of the metal storage rack used to hold the LFH and *** in the sterile non-hazardous cleanroom.

On 11/29/22, the *** hood was observed to be used in the production of 100 mL of Niacinamide 100 mg/mL injectable 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): Aseptic processing areas had visibly dirty equipment or surface

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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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