TCI Co., Ltd BioCosme PABP BRANCH – FDA Warning Letter, Mar 13, 2026

FDA issued a warning letter to TCI Co., Ltd BioCosme PABP BRANCH following an inspection from March 9 to March 13, 2026, at its facility in Pingtung County, Taiwan. The inspection identified significant violations of Current Good Manufacturing Practice (CGMP) regulations under the Federal Food, Drug, and Cosmetic Act, resulting in the firm"s over-the-counter (OTC) drug products being deemed adulterated.

The primary violations involved a failure to perform essential laboratory testing. The company released drug products to the U.S. market without verifying the identity and strength of active ingredients. Additionally, TCI failed to adequately test incoming raw materials and relied on supplier certificates of analysis without establishing their reliability. Notably, the firm did not conduct critical safety tests for toxic contaminants like diethylene glycol in high-risk ingredients. Further issues included inadequate manufacturing process validation and a failure to properly qualify the water system used in production. The Quality Control Unit also lacked sufficient oversight, allowing unauthorized changes to manufacturing processes and failing to maintain proper production records.

In response, the FDA requires TCI Co., Ltd to implement comprehensive corrective actions. These include providing a detailed quality agreement with customers, establishing robust chemical and microbial testing protocols, and submitting a summary of their process validation program. Although the company has currently suspended drug registration, they must notify the FDA and hire a qualified third-party consultant to conduct a full-system audit before resuming manufacturing for the U.S. market. Failure to address these deficiencies may lead to the FDA refusing entry of the company’s products into the United States.