FDA 483 - Sinopep-Allsino Biopharmaceutical Co., Ltd. - September 20, 2024

An FDA inspection of Sinopep-Allsino Biopharmaceutical Co., Ltd in Lianyungang, China, revealed critical deficiencies in manufacturing practices. Observations included inadequate cleaning of major production equipment leading to API residue and foreign object contamination, as well as poor facility maintenance with water leaks in storage and laboratory areas. Additionally, the firm failed to implement effective pest control measures, resulting in insects and cobwebs in raw material storage.