FDA 483 - Pharmaceutics International Inc - October 30, 2020

Pharmaceutics International Inc, a drug manufacturer in Hunt Valley, MD, was cited for significant deficiencies across its quality system, facilities, and laboratory controls. Observations included inadequate employee training, lack of proper quality control unit oversight for raw materials and dissolution testing, poor facility maintenance with a compromised HEPA filter, and critical issues with data integrity and computer system controls, including unauthorized data alterations and lack of audit trail review.