FDA 483 - Central Admixture Pharmacy Services, Inc. - February 22, 2013

The FDA Form 483 details significant violations at a drug compounding facility, primarily concerning the separation of penicillin/cephalosporin processing from other human drug products, and sterile manufacturing controls.

**Facility and Operations:** The facility compounds penicillin, cephalosporin, and other human drug products like Oxytocin and Cardioplegia.

**Violations and Observations:** 1. **Inadequate Separation of Penicillin Operations:** * Air-handling systems for the Antibiotic room (penicillin/cephalosporin compounding) also supply air to the Ante Room, Gowning Room, and Product room. Exhaust from the Antibiotic room enters a non-classified area that supplies air to the TPN room (other human compounding). * The Antibiotic room was at a higher pressure than the adjacent TPN compounding room, risking cross-contamination. * Personnel handling penicillin/cephalosporin products were not adequately segregated from those handling other human drug products. Examples include: * Compounding personnel entering the Antibiotic room to retrieve diluents for Oxytocin compounding in the TPN room. * Re-usable non-sterile gowning for all operators, including those from the Antibiotic room, was not segregated. * (b)(4) (disinfectant) refilled in the Antibiotic room was used at ISO 5 workstations in the TPN room for other products.

2. **San