FDA 483 - Pharmaceutics International, Inc. - November 14, 2022

Pharmaceutics International Inc. in Cockeysville, MD, a drug product manufacturer, was cited with ten observations during an FDA inspection. The inspection revealed significant deficiencies across multiple areas, including inadequate investigations into out-of-specification results, failures in maintaining aseptic processing environments, insufficient cleaning and maintenance procedures, and a lack of proper validation for analytical methods and manufacturing processes. These issues indicate a systemic breakdown in quality control and adherence to cGMP requirements for sterile drug product manufacturing.