FDA 483 - SEL Biochem Xinjiang Co., Ltd - March 25, 2019

SEL Biochem Xinjiang Co. Ltd., an API manufacturer in Shihezi, China, was cited for significant deficiencies during an FDA inspection. Observations included inadequate manufacturing equipment cleaning procedures and validation, lack of hot water and hand detergent in critical workshop areas, and insufficient calibration of in-process control equipment. Additionally, test procedures for API-related samples and cleaning samples were found to be deficient.