FDA 483 - Pharmaceutics International Inc - November 09, 2018
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 9e005824-a2d7-45ef-897c-1a863e8ef353