FDA 483 - Pharmaceutics International Inc - March 24, 2017

Pharmaceutics International Inc. in Hunt Valley, MD, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate investigations into product failures and discrepancies, a backlog of unaddressed customer complaints and quality events, and a failure to complete annual product reviews. Additionally, the firm lacked appropriate controls over electronic records for change controls and work orders, indicating a systemic issue with data integrity and quality oversight.