Chongqing Qiancan Technology Co., LTD – FDA Warning Letter, Jun 30, 2026

This Warning Letter, dated October 29, 2026, was issued by the FDA to Chongqing Qiancan Technology Co., Ltd. (CQT), an active pharmaceutical ingredient (API) manufacturer located in Chongqing, China. The citation follows the company"s failure to provide records and information requested by the agency under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic (FD&C) Act. On June 17, 2026, the FDA requested documentation to verify the quality of APIs manufactured by CQT and distributed to the U.S. market for prescription compounding. Instead of providing the records, the firm briefly de-registered its facility and stated it was unable to meet FDA requirements. Although CQT re-registered in July 2026, the requested documentation remained unsubmitted. The refusal to permit access to these records is a prohibited act under the FD&C Act, as it prevents the FDA from confirming the quality and safety of the drugs. Consequently, the FDA placed the firm on Import Alert 66-79 on August 26, 2026, and may withhold approval of any new applications involving the firm. CQT is required to submit a written response within 15 business days detailing corrective actions and may request an FDA inspection to demonstrate compliance with Current Good Manufacturing Practice standards.