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

This FDA Form 483, issued to Central Admixture Pharmacy Services, Inc. in Livonia, MI, following an inspection from February 19-22, 2013, details seven observations regarding their sterile drug product manufacturing.

**Facility and Equipment Deficiencies:** 1. **Inadequate Air-Handling Systems:** The air-handling system for penicillin and cephalosporin compounding (Antibiotic room) is not completely separate from other human drug product areas (Ante Room, Gowning Room, Product room, TPN room). Exhaust from the Antibiotic room enters a non-classified area that also supplies air to the TPN room. Pressure differential monitoring on 2/19/2013 showed the Antibiotic room at a higher pressure than the adjacent TPN room, risking cross-contamination. Products like Ceftriaxone, Cefazolin, Penicillin G potassium, and Oxytocin were compounded in these interconnected areas. 2. **Lack of Segregation in Operations:** Procedures for separating tasks and segregating personnel handling penicillin/cephalosporin from other drug products are not established. Examples include: * An employee entering the Antibiotic room to retrieve diluents for Oxytocin compounding in the TPN room, after Ceftriaxone was compounded in the Antibiotic room. * Re-usable, non-sterile gowning was not segregated, including gowns used by operators in the antibiotic