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

The FDA Form 483 details significant deficiencies at a drug compounding facility.

**Facility and Operations:** The facility compounds various drug products, including penicillin, cephalosporin, TPN, Oxytocin, Cardioplegia, and Magnesium Sulfate.

**Violations and Observations:**

1. **Inadequate Separation of Penicillin Operations:** * Air-handling systems for penicillin and cephalosporin products (Antibiotic room) are not completely separate from other drug products (Ante Room, Gowning Room, Product room, TPN room). * The Antibiotic room's exhaust vents into a non-classified area that also supplies air to the TPN room's Air Handling Unit. * Pressure differential monitoring on 2/19/2013 showed the Antibiotic room at a higher pressure than the adjacent TPN compounding room. * Personnel and materials handling penicillin/cephalosporin products were not adequately segregated from those for other human drug products. Examples include: * Compounding personnel entering/exiting the Antibiotic room to retrieve diluents for Oxytocin compounding in the TPN room. * Non-sterile, re-usable gowning for operators, including those from the Antibiotic room, was not segregated. * Disinfectant (b)(4) refilled in the Antibiotic room was used in the TPN room for other products.

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