FDA 483 - Central Admixture Pharmacy Services, Inc. - February 27, 2013

The FDA Form 483 details significant deficiencies at a drug product manufacturing facility, impacting the production of sterile products like Oxytocin, Adenocaine, Lipid Syringes, TPN, Cardioplegic Solution, Continuous Renal Replacement Therapy, and Diltiazem.

Key violations include: - **Inadequate Laboratory Controls:** No established sterility or endotoxin testing procedures for each batch prior to release and distribution. Products are distributed before receiving passing results from an outside laboratory. - **Microbiological Contamination Prevention:** Procedures to prevent contamination of sterile drug products are not fully established or followed. - **Contaminant Ingress:** Insufficient procedures and controls to mitigate contaminant ingress into ISO 5 hoods. - **Gowning and Aseptic Technique Deficiencies:** - Personnel observed with exposed skin (neck, face) entering hoods, violating laminar air space. - Gowning SOP is silent on sterile gowning requirements. - Personnel not wearing goggles, hoods, hair nets, or face masks. - Inconsistent hand sanitization; some personnel applied sanitizers without proper rubbing. - Glove and sterile sleeve change-out intervals are not detailed in procedures, leading to personnel working extended periods without changes. - **Equipment and Area Cleanliness:** - Plastic holders in ISO 5 hoods, containing unsterile items, are not removed and cleaned daily. - Aftermarket hood guards, not part of original design, are