FDA 483 - Guang'an Kingday Pharma & Chem Co. Ltd. - May 20, 2024

An FDA inspection of Guang'An Kingday Pharma & Chem Co. Ltd., an API manufacturer in Guang'An, China, revealed significant deficiencies in quality control. Observations included inadequate monitoring of the water system for objectionable microorganisms, insufficient controls for computerized inventory systems, and a failure to routinely monitor cleaning procedures after initial validation. These issues indicate a lack of robust quality assurance practices.