FDA 483 - Pharmaceutics International Inc - November 09, 2018

An FDA inspection of Pharmaceutics International Inc. in Hunt Valley, MD, from October 23 to November 9, 2018, revealed significant deficiencies in the manufacturing of non-sterile human and animal drugs. The firm exhibited systemic failures across quality control, laboratory operations, investigation processes, material storage, and facility maintenance. These issues indicate a lack of adherence to established procedures and regulatory requirements, potentially impacting drug product quality and integrity.