Apothecus Pharmaceutical Corp. – FDA 483, Nov 15, 2024

Apothecus Pharmaceutical Corp. in Hicksville, NY, a non-sterile human drug manufacturer, was cited for multiple significant deficiencies during an FDA inspection. The observations primarily concern inadequate controls over labeling, failure to follow written production procedures, poor data integrity practices for computer systems, and deficiencies in quality control unit procedures, discrepancy investigations, and product complaint handling. These issues indicate a systemic lack of adherence to cGMP requirements.