FDA 483 - Medical Products Laboratories, Inc. - March 13, 2020

Medical Products Laboratories, Inc. in Philadelphia, PA, a contract manufacturer of Rx and OTC drug products, was cited with five observations during an FDA inspection from February 24 to March 13, 2020. The inspection revealed significant deficiencies in quality control unit procedures, investigation processes for discrepancies and complaints, equipment cleaning validation, process control documentation, and laboratory controls for water system specifications. These issues indicate a lack of adherence to cGMP requirements, potentially impacting product quality and safety.