FDA 483 - Apothecus Pharmaceutical Corp. - October 06, 2023

Apothecus Pharmaceutical Corp. in Hicksville, NY, was cited for significant deficiencies in its manufacturing operations for VCF Contraceptive Film and Gel. The inspection revealed critical failures in out-of-specification investigations, component testing, quality unit oversight, process validation, labeling control, and change control procedures, indicating a systemic lack of adherence to cGMP regulations. These issues raise concerns about the identity, strength, purity, and quality of distributed drug products.