FDA Warning Letter issued due to no response

Recommendation

22/23 February 2024
Munich, Germany

API Regulatory Starting Materials
Definition, Manufacture, Assessment and handling post-approval Changes

In June 2023, the U.S. FDA issued a Warning Letter to the Chinese company "Chengdu KeCheng Fine Chemicals Co., Ltd.". According to the Warning Letter, the company is registered within the USA as an API manufacturing facility, which shipped APIs to the U.S. several times.

The electronical requests of the U.S. FDA to send records and further information regarding the shipped APIs were almost disregarded and unanswered. Due to the fact that the firm failed to respond probably to these requests and the associated communication, the U.S. FDA stated that there is no indication of the level of quality assurance for drugs listed as manufactured at Chengdu KeCheng Fine Chemicals Co., Ltd.".

The observed findings resulted in an Import Alert for all drugs and drug products manufactured at the company's facility and the U.S. FDA stated they may withhold approval of any new applications or supplements of the firm. Additionally, shipped articles produced by Chengdu KeCheng Fine Chemicals Co., Ltd. into the U.S. may be refused for admission, if the goods appear to be adulterated or misbranded.

To view the complete list of violations and the conclusion given by the U.S. FDA, please see the Warning Letter Chengdu KeCheng Fine Chemicals Co., Ltd