FDA 483 - Mooney's Pharmacy, Inc. - September 02, 2016

This FDA Form 483 documents observations from an inspection of a facility producing beta-lactam and hazardous drugs. The facility failed to provide adequate containment, segregation, and/or cleaning to prevent cross-contamination.

Specifically, the firm prepared an amoxicillin/clavulanic acid solution by crushing Augmentin tablets in a multi-use compounding room lacking a powder hood. Similarly, Fluorouracil 5.25% cream was prepared using bulk Fluorouracil USP powder in the same multi-use compounding room, also without a powder hood.

Further observations noted that production areas have difficult-to-clean, particle-generating, and visibly dirty surfaces. The ceiling and floors in the compounding room are not constructed of readily cleanable materials; the floor is carpeted, and the ceiling is textured popcorn-coated drywall. On August 29, 2016, black and brown stains were observed on the ceiling in the compounding room directly above the work area. These conditions indicate deficiencies in maintaining a clean and controlled environment suitable for drug production, posing risks of contamination and compromising product quality and patient safety.