FDA 483 - Stewart Compounding Pharmacy - March 25, 2013

The FDA Form 483 details significant deficiencies at a drug product manufacturing facility. The facility failed to perform sterility or endotoxin testing on Human Chorionic Gonadotropin/Vitamin B12 Injection products (pre-filled syringes or vials) from November 2012 to present, and on Cyanocobalamin (Vitamin B12) Injection from 2012 to present, despite expiration dates ranging from 7 to 180 days.

Sterilization processes for sterile injectable products, including HCG/Vitamin B12, were not validated. Aseptic filling for HCG/Vitamin B12 was conducted outside the clean room in an unclassified area, and the product was not sterile filtered or terminally sterilized. The sterilization of Mannitol Powder, USP, used in HCG formulation, was not validated. Sterilization cycles for ophthalmic products and instruments were not validated, and biological indicators were not routinely used to monitor these processes.

Potency testing for HCG/Vitamin B12 revealed significant inconsistencies, with one lot failing potency at 229% and later at 37.6%, leading to undocumented remixing and dosage adjustments. The firm's written stability testing program was not followed, lacking stability and sterility data to support assigned expiration dates.

Procedures to prevent microbiological contamination were not established or followed, including failure to filter certain products and use of expired components. Sterilization/depyrogenation cycles for