Taiwan's TCI let its FDA drug registration lapse rather than fix its quality system

On September 2, 2026, the FDA sent a warning letter to TCI Co., Ltd.'s BioCosme PABP Branch, a Taiwanese contract plant in Changzhi Township, Pingtung County, after a March 9–13, 2026 inspection found its methods and controls did not conform to Current Good Manufacturing Practice, rendering its over-the-counter drug products adulterated under US law.

The core failure was testing — or the absence of it. The plant released OTC batches to the US market without assay testing of the active ingredient, and accepted incoming components on suppliers' certificates of analysis without ever validating those results, with no written procedure or quality agreement defining who tests what. FDA's letter noted that ingredients contaminated with the redacted hazard class at issue 'has resulted in various lethal poisoning incidents in humans worldwide'.

The paper trail made it worse: the plant validated its drug process with a document titled 'Process Validation for Cosmetic Products', whose batch records didn't match what was actually made, and its water system had never been qualified with total organic carbon, conductivity or microbial testing. Its April 2 response was rejected as inadequate — no supporting documentation, no evidence of corrective action. R&D staff, FDA found, had been adjusting process parameters on the factory floor without any change control.

Then came the decision that gives the case its shape: during the inspection, TCI told the agency it would simply let its FDA drug registration expire, renewing 'if a U.S. order is received'. FDA's response was to condition any resumption of drug manufacturing on prior notification, a qualified consultant, and a six-system audit — and to warn that plant output may be detained or refused admission at the border.

Its US drug registration lapsed during the inspection, suspending production; FDA warned articles from the plant may be detained or refused at the border.

Batches were shipped to US consumers before anyone verified the drug inside was the strength on the label.

The plant leaned on suppliers' paper instead of testing — precisely the shortcut behind the deadliest glycol-poisoning episodes in drug history.

A cosmetic validation document doing a drug's job captures the whole quality culture in one file name.

Rather than remediate, the firm chose to exit — and FDA made re-entry conditional on a full audit first.

A contract manufacturer owns the quality system even when the customer owns the brand — 'the client didn't ask for that test' has never cleared an FDA inspection.

The FDA told the plant to notify the agency before resuming any drug manufacturing, engage a qualified consultant, and complete a six-system CGMP audit with all corrective actions verified. The source records no US orders since.