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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.