FDA 483 - Apothecus Pharmaceutical Corp. - May 17, 2021

Apothecus Pharmaceutical Corp. in Hicksville, NY, was inspected by the FDA from April 30 to May 17, 2021, revealing significant deficiencies in its manufacturing and quality control processes for drug products, including vaginal contraceptive film, gel, and foam. The inspection identified repeat observations related to data integrity, laboratory controls, and OOS investigations, alongside new findings concerning quality unit responsibilities, employee training, process validation, deviation management, and facility maintenance. These issues indicate a systemic lack of adherence to cGMP regulations, posing potential risks to product quality and patient safety.