FDA 483 - Central Admixture Pharmacy Services, Inc. - February 20, 2014

The FDA Form 483 details multiple observations from an inspection of a facility compounding sterile preparations.

**Observation 1** notes inadequate separation of penicillin and cephalosporin drugs from other drug products, increasing cross-contamination risk. Penicillin G Potassium and cephalosporin drugs are compounded in the same Laminar Air Flow (LAF) Hoods as Cardioplegia Solution, Total Parenteral Nutritionals (TPN), and Continuous Renal Replacement Therapy (CRRT) solutions, sometimes simultaneously or sequentially on the same day.

**Observation 2** indicates that sterility testing samples are not representative, with numerous compounded preparations (e.g., Cardioplegia Solution, Oxytocin, Magnesium Sulfate, Norepinephrine) not sampled for sterility testing as required by procedure TP-CAPS-4000037.

**Observation 3** highlights deficiencies in environmental monitoring. Total Particulate Count and Active Air sampling are not performed each operational shift in critical zones (ISO 5 LAF hoods, TPN work zones), and Surface Monitoring is not performed daily. Personnel monitoring is limited, and environmental microbial monitoring of floor surfaces and frequently contacted surfaces (e.g., handles of portable carts, amino acid storage shelf cover) is not conducted.

**Observation 4** identifies unsuitable building construction. The unclassified space adjacent to the cleanroom is contiguous with the warehouse and shipping/receiving area, lacking adequate protection from the outdoor environment, with insect carcasses observed. An exit pass-