FDA 483 - Barclay, Luke, & Pillai Specialty Pharmacy, PLLC - December 09, 2022

This FDA Form 483 details observations from an inspection of Barclay, Luke, & Pillai Specialty Pharmacy, PLLC, a producer of sterile and non-sterile drug products, conducted from November 28 to December 9, 2022. Sean M. Barclay is the Owner and Pharmacist-in-Charge.

Key observations include:

1. **Unclean Aseptic Processing Areas:** ISO 5 classified aseptic processing hoods in the sterile non-hazardous cleanroom were visibly dirty, with fibrous material, a discolored equipment ID sticker, apparent splatter marks on a HEPA filter, and a crack in a plastic sash. One hood was used to produce Niacinamide 100 mg/mL injectable solution.

2. **Non-Microbial Contamination:** Sterile non-hazardous and sterile hazardous cleanrooms contained difficult-to-clean, particle-generating, or visibly dirty surfaces. This included apparent rust on multiple metal surfaces (e.g., refrigerator casters, cart casters, hinges, machine tabletops, BSC support legs, screwheads, stool feet), uncovered sprinkler heads, and apparent cleaning chemical residue on window walls and hood sashes.

3. **Unsealed Ceiling Tiles:** Unsealed, loose ceiling tiles were observed directly above the ISO 5 biosafety cabinet in the ISO 7 sterile hazardous cleanroom and in the ISO 7 sterile non-hazardous cleanroom, where a tile became dislod