FDA WARNING_LETTER - Yangzhou Hongshengding Chemical Co.,Ltd. - June 01, 2026

On June 15, 2026, the FDA issued a Warning Letter to Yangzhou Hongshengding Chemical Co., Ltd. (YHC), a manufacturer of over-the-counter drug products based in Yangzhou, China. The enforcement action follows the company’s repeated failure to provide requested records to the agency, which constitutes a violation of the Federal Food, Drug, and Cosmetic Act. Under the regulatory framework of Section 704(a)(4), the FDA is authorized to request manufacturing records to ensure product quality and safety. Between January and March 2026, the FDA made several electronic and written attempts to obtain information from YHC and its U.S. Agent. Although the company received these communications and was granted an extension, it failed to respond or produce the required documents. Consequently, the FDA cannot verify the quality assurance standards of the drugs being shipped from this facility to the U.S. market. As a result of these violations, the FDA placed all drug products from this firm on Import Alert 66-79 on June 3, 2026, meaning shipments may be detained or refused entry into the United States. Furthermore, the agency may withhold approval of any new drug applications that list YHC as a manufacturer until compliance is established. To address these issues, Yangzhou Hongshengding Chemical Co., Ltd. is required to respond in writing within 15 working days. The response must include information for the agency’s consideration or a formal request for an FDA inspection to confirm the facility’s compliance with manufacturing standards.