FDA 483 - Custom Compounding Centers, LLC - December 13, 2012

This FDA Form 483 details multiple observations from an inspection. The firm rejected and destroyed sterile injectable drug products (Betamethasone Na Phos, Wydase, Morphine Sulfate 90mg/ml, Omnipaque, Ondansetron 2mg, Morphine sulfate 1mg/ml) due to failed or questionable sterility/fungal testing without investigation, root cause determination, or impact assessment. One lot (Promethazine 25mg/ml) was released despite unclear sterility results for one sample. The firm did not identify the genus/species of microorganisms found.

The firm does not conduct sterility and endotoxin testing at the end of drug product shelf lives as per procedure PH103, nor does it require storing vials in various positions for contact with containers/closures. Employees enter ISO 5 areas in street clothes under non-sterile gowns, with exposed facial areas, and uncontrolled movement, potentially introducing particulates/microbes. The maximum number of personnel in clean rooms is not established.

The firm did not review or approve bacterial/fungal air results from an independent company against USP <797> standards, lacking clear conclusions. Dust accumulated in ISO 5 return vents, which are not included in cleaning logs. Environmental monitoring (viable/non-viable) is not performed during aseptic filling, and personnel monitoring (hand, chest, mask, head) is not conducted, only glove monitoring. Non-sterile hair nets, face masks,