FDA WARNING_LETTER - Chengdu KeCheng Fine Chemicals Co., Ltd. - June 08, 2023

The FDA issued a Warning Letter to Chengdu KeCheng Fine Chemicals Co., Ltd. on June 20, 2023, for refusing to provide records requested under section 704(a)(4) of the FD&C Act. The firm, registered as an API manufacturer, continued shipping APIs to the U.S. despite a stated intent to deregister.

The FDA sent electronic requests for records on July 18, 2022, and August 8, 2022, followed by a phone call on October 24, 2022, during which the firm refused to provide information or an alternate email. A follow-up request was sent on March 9, 2023. The firm failed to respond to any of these communications.

This refusal to permit access to records is a prohibited act under section 301(e) of the FD&C Act. Due to the lack of response, the FDA has no indication of the quality assurance for drugs manufactured by the firm. Consequently, all drugs and drug products from this firm were placed on Import Alert 66-79 on June 8, 2023. The FDA may withhold approval of new applications listing this firm as a manufacturer, and shipments may be detained or refused admission under section 801(a)(3) of the FD&C Act.

The firm must respond in writing within