FDA Bars Chengdu KeCheng Drugs

FDA says all drugs and drug products manufactured by Chengdu KeCheng Fine Chemicals in Chengdu Shi Sichuan Sheng, China, were placed on an Import Alert 6/8. A 6/20 Warning Letter says the action follows several company refusals to provide records and other information sought by the agency. Chengdu is registered with FDA as a manufacturer of several active pharmaceutical ingredients (APIs), the letter says.

In a 10/24/22 telephone call, the letter says, the company declined to identify officials or give an alternate email address for further communications. The company said it was not shipping products to the U.S. and would deregister the firm as a drug establishment.

However, FDA says, it continued to ship API to the U.S. as recently as January and continued to not respond to requests for records and information.

Chengdu was told to respond with information for FDA to consider as it assesses the company’s activities and practices, or it can request to schedule an FDA inspection.