Chine API Manufacturer Chengdu KeCheng Issued Warning Letter and Import Alert for Refusal of Information

The USFDA issued a Warning Letter to the Chinese API manufacturer Chengdu KeCheng Fine Chemicals Co., Ltd. in June 2023 for refusal of information and records. Chengdu KeCheng had registered with the FDA as a manufacturer of several Active Pharmaceutical Ingredients (APIs) and exported these APIs to the U.S. market.

In July 2022 the FDA requested Chengdu KeCheng to provide records and information as required under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic (FD&C) Act. FDA followed up on the request in August and October 2022, but Chengdu KeCheng repeatedly refused to provide the requested information and also denied shipping APIs to the U.S..Chendu Kecheng agreed to deregister the Firm as a drug establishment; however it continued to ship APIs to US

Further FDA placed all drugs and drug products manufactured by Chengdu KeCheng on Import Alert 66-79 on June 8, 2023. FDA places drugs and drug products manufactured by a Firm under Import Alert 66-79 when it refuses an inspection by USFDA or delays, denies or limits an inspection.

Import Alert 66-79: “The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.”

Till FDA is able to confirm compliance of the firm with cGMP requirements any drug shipments from the firm will be detained or refused admission into the U.S. (Detention Without Physical Examination (DWPE). The FDA may also hold approval of new drug applications listing Chengdu KeCheng as a drug manufacturer.