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