FDA 483 - Apothecus Pharmaceutical Corp. - November 15, 2024

Apothecus Pharmaceutical Corp. in Hicksville, NY, was cited for multiple significant deficiencies during an FDA inspection. Observations included inadequate control over labeling, failure to follow written production and process control procedures, and insufficient data integrity controls for laboratory systems. The firm also demonstrated deficiencies in quality control unit procedures, failure to investigate unexplained discrepancies, and non-adherence to product complaint handling procedures.