Tianjin Healthcare Medical Technology Co., Ltd. – FDA Warning Letter

The U.S. Food and Drug Administration (FDA) issued a warning letter on October 29, 2026, to Tianjin Healthcare Medical Technology Co., Ltd. (THM), a manufacturer of active pharmaceutical ingredients (APIs) based in China. The letter follows a regulatory records review initiated on June 17, 2026, which identified significant violations regarding the firm"s compliance with federal transparency requirements. The primary issue involves THM’s refusal to provide records requested by the FDA under the Federal Food, Drug, and Cosmetic (FD&C) Act. Despite multiple requests and follow-up communications, the firm declined to supply documentation necessary for the FDA to assess the quality of drugs exported to the United States. Although THM indicated they would stop production for the U.S. market, the FDA clarified that this does not exempt the company from providing records for products currently in distribution and still within their expiration dates. Due to this lack of cooperation, the FDA placed THM on Import Alert 66-79 in August 2026, allowing for the detention of their products at the border. The FDA also noted that until compliance is verified, the agency may withhold approval for any new drug applications involving the facility. To address these violations, THM is required to submit a written response within 15 business days detailing their corrective actions. If the company intends to resume U.S. distribution, they must request a formal FDA inspection. Conversely, if they have ceased operations, they must update their official registration and drug listings within 30 days as required by federal regulations. Failure to resolve these issues may result in further regulatory action without notice.