FDA 483 - Pharmakon Compounding Pharmacy, Inc. - May 06, 2016

The FDA Form 483 details numerous deficiencies at a facility producing sterile drug products. Key issues include inadequate validation of sterilization processes and aseptic process simulations (media fills), with specific concerns about worst-case conditions, lot sizes, and container closure systems. Personnel performing aseptic processes, including technicians and pharmacists, were observed producing sterile lots (e.g., Epinephrine 1 mg/ml, Cefuroxime 10 mg/ml) without documented media fill validation.

Smoke studies for ISO 5 areas were found to be deficient, lacking documentation of dynamic conditions. Procedures for preventing microbiological contamination were not established or written. Observations during production of Epinephrine and Phenylephrine/Tropicamide included unsanitized non-sterile syringes, obstructed airflow in critical areas, and infrequent replacement of critical supplies.

Aseptic processing areas were deficient in maintaining equipment and environmental control. ISO 5 laminar flow hoods were located in unclassified rooms, increasing contamination risk, and their HEPA filters showed failures. Environmental monitoring was insufficient, not performed daily or under dynamic conditions, and media plates lacked disinfectant neutralizers.

Cleaning and disinfection procedures were inadequate, with no assessment of disinfectant efficacy or cleaning equipment suitability. Personnel garb was inappropriate, with non-sterile items and exposed skin observed in aseptic areas.

Drug product testing and release were severely deficient. Sterile products were released without potency testing (e.g., Epinephrine, Phenylephrine/Tropicamide, Lidocaine/Epinephrine