FDA EIR - SEL Biochem Xinjiang Co., Ltd - March 29, 2019

An FDA surveillance inspection of SEL Biochem Xinjiang Co. Ltd., an active pharmaceutical ingredient manufacturer in Shihezi, China, took place from March 25-29, 2019. Conducted under FDA procedures for API and animal drug manufacturing inspections, with guidance from ICH Q7 and adherence to Good Manufacturing Practices (GMP) as per the Food, Drug and Cosmetic Act, the inspection revealed several significant deficiencies. Key issues included inadequate manufacturing equipment cleaning procedures and validations, evidenced by visible residues in supposedly cleaned tanks and insufficient cleaning verification. Facility-related violations involved the absence of hot water and hand detergent in workshop toilets and gowning areas, along with a broken drain pipe. Calibration of in-process control equipment for moisture content analysis was found to be deficient, lacking proper temperature calibration. Additionally, test procedures for API samples were flawed, specifically concerning HPLC identification calculation methods and the validation range for cleaning sample analysis. At the inspection's conclusion, a 4-item FDA Form 483, detailing these observations, was issued to the General Manager. The company committed to providing a written response outlining corrective actions within 15 business days.