FDA WARNING_LETTER - Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd. - July 07, 2025

On August 6, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd. following a records review initiated in July 2025. The review identified significant deviations from Current Good Manufacturing Practice (CGMP) standards at the company’s facility in Tianjin, China, which manufactures active pharmaceutical ingredients (APIs). The primary violations include the distribution of APIs to the United States without adequate process validation; the company claimed products were still in development despite distributing them to pharmacies. Furthermore, the firm failed to maintain complete master production records, lacked validated analytical testing methods to ensure product quality, and did not establish a stability testing program to guarantee the safety of drugs through their expiration dates. The FDA also noted drug listing violations for products such as demecarium bromide and chlorambucil, which were not properly registered under the company"s labeler code. Under the Federal Food, Drug, and Cosmetic Act, these failures categorize the products as adulterated and misbranded. As a result, the FDA placed the company on an import alert in July 2026. Required actions include performing a comprehensive risk assessment of distributed products, hiring independent consultants to evaluate laboratory and manufacturing systems, and providing a detailed timeline for validating all manufacturing processes. Failure to address these concerns may lead to continued refusal of the company’s products into the U.S. market.