Chengdu KeCheng Fine Chemicals Co., Ltd.

Warning LetterOpen

Mr. Ye General Manager Chengdu KeCheng Fine Chemicals Co., Ltd. Floor 9, No. 18 Chuangye Road Chengdu High-Tech District Chengdu Shi Sichuan Sheng , 610000 ChinaFEI 3014675751Issued Jun 20, 2023Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3014675751.

Violations2

Issue DateJun 20, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Chengdu KeCheng Fine Chemicals Co., Ltd.
Location: Mr. Ye General Manager Chengdu KeCheng Fine Chemicals Co., Ltd. Floor 9, No. 18 Chuangye Road Chengdu High-Tech District Chengdu Shi Sichuan Sheng , 610000 China
FEI Number: 3014675751
Country: China
Issue Date: June 20, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Chengdu KeCheng Fine Chemicals Co., Ltd., an active pharmaceutical ingredient (API) manufacturer, failed to comply with FDA records requests under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act despite multiple communication attempts between July 2022 and March 2023. The company refused to provide requested records and other information, claiming it was not shipping products to the U.S. while continuing to do so through at least January 2023, leaving the FDA with no means to assess the quality assurance of drugs manufactured at the facility. As enforcement action, the FDA placed all drugs and drug products manufactured by the company on Import Alert 6.

Chengdu KeCheng Fine Chemicals Co., Ltd. FDA Warning Letter, June 20, 2023