Cheng Fong Chemical Co. Ltd is a Chinese active pharmaceutical ingredient (API) company that exports to the United States of America.[1] In September 2016, the US FDA issued a warning letter "following a five-day inspection in April 2016 that found the company failed to appropriately maintain its facilities and investigate reports of foreign particles in finished batches."[2] According to the FDA, Cheng Fong officials told investigators "that the rooms had never been cleaned.".[1]
References
- Mezher, Michael. The Rooms Have Never Been Cleaned': Two New FDA Warning Letters for Chinese Manufacturers RAPS, 27 September 2016, retrieved 28 September 2016^
- Cheng Fong Chemical Co., Ltd. 9/15/16 - Warning Letter 320-16-33 US FDA, 15 September 2016, retrieved 28 September 2016^