FDA 483 - Shouguang Fukang Pharmaceutical Co., Ltd. - May 25, 2018

Shouguang Fukang Pharmaceutical Co., Ltd., an API manufacturer in Shouguang City, China, was cited for significant quality control and manufacturing deficiencies during an FDA inspection. Findings included unreliable laboratory data, commercial release of drug substances failing specifications without adequate investigation, and unsanitary conditions in both manufacturing equipment and storage areas. Additionally, the firm failed to maintain clean laboratory glassware.