FDA 483 - Sinopep-Allsino Biopharmaceutical Co., Ltd. - April 11, 2014

Sinopep Jiangsu Inc., an Active Pharmaceutical Ingredient Manufacturer in Lianyungang, Jiangsu, China, was inspected by the FDA. The inspection revealed significant deficiencies across quality, facility, material, production, and laboratory systems. Key issues included inadequate investigations of unknown peaks, unapproved equipment qualifications, insufficient cleaning and manufacturing process validations, and improper raw material dating and stability conditions.