FDA 483 - Pharmaceutics International Inc - September 29, 2021

Pharmaceutics International Inc., a non-sterile drug manufacturer in Hunt Valley, MD, was cited for significant deficiencies across its quality, facilities, equipment, production, and material systems. The inspection revealed repeated failures in thorough investigations of discrepancies, inadequate quality control unit procedures, and insufficient controls over electronic equipment and data. These issues indicate a systemic lack of adherence to cGMP regulations, posing risks to drug product quality and integrity.