Pharmaceutics International Inc – FDA 483, Nov 9, 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.