FDA 483 - Pharmaceutics International Inc - March 18, 2016

An FDA inspection of Pharmaceutics International Inc. in Hunt Valley, MD, a drug manufacturer, revealed significant deficiencies across multiple systems. Repeated observations included inadequate environmental controls and HVAC monitoring, insufficient cleaning validation and procedures, and critical failures in data integrity and quality control unit oversight. The firm also failed to thoroughly investigate discrepancies and maintain proper production documentation, indicating systemic issues in GMP compliance.