FDA 483 - Chifeng Pharmaceutical Company, Ltd. - October 13, 2017

Chifeng Pharmaceutical Co., Ltd. in Chifeng, P.R. China, an Active Pharmaceutical Ingredient Manufacturer, received a Form 483 with nine observations. The inspection revealed significant issues across contamination control, material management, deviation documentation, equipment qualification, record-keeping, quality reviews, software validation, and pest control. These findings indicate a broad lack of adherence to good manufacturing practices, posing potential risks to product quality and integrity.