FDA 483 - Chifeng Pharmaceutical Company, Ltd. - January 19, 2024

An FDA inspection of Chifeng Pharmaceutical Co, Ltd's Active Pharmaceutical Ingredient manufacturing facility in Chifeng, China, revealed significant deficiencies in quality control and facility maintenance. Observations included unvalidated test methods, an inadequate cleaning validation program, unqualified equipment, and poor building and equipment upkeep. These findings indicate a lack of adherence to good manufacturing practices.