FDA 483 - Qilu Pharmaceutical Co., Ltd. - February 22, 2018

An FDA inspection of Qilu Pharmaceutical Co., Ltd., an Active Pharmaceutical Ingredients manufacturer in Licheng, Jinan, Shandong, China, revealed significant deficiencies in their quality system. The firm failed to adequately investigate non-conformances and performed temperature mapping studies inadequately. These issues raise concerns about the quality and integrity of APIs distributed in the US.