FDA 483 - Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd. - May 19, 2017

An FDA inspection of Guangdong Zhanjiang Jimin Pharmaceutical Co., Ltd. revealed significant deficiencies in the manufacturing of Piyanping 1% Hydrocortisone Lotion. Key issues included product mislabeling, with the lotion containing Dexamethasone instead of Hydrocortisone, and a lack of essential quality control testing. The firm also failed to maintain adequate facility hygiene, proper recall procedures, equipment qualification, and complete batch records.