Apothecus Pharmaceutical Corp. – FDA 483, Apr 30, 2019

Apothecus Pharmaceutical Corp. in Hicksville, NY, a pharmaceutical drug manufacturer, was cited for multiple significant deficiencies in its quality control and manufacturing processes. Key issues include inadequate testing and method validation for contraceptive products, insufficient out-of-specification investigations, and a lack of equipment cleaning validation. Additionally, the firm demonstrated personnel shortages leading to testing backlogs, poor computer system controls, and inadequate temperature monitoring for drug storage, indicating a systemic lack of adherence to GMP requirements.