Drugs · Sep 2, 2026

TCI Co., Ltd BioCosme PABP BRANCH

8 extracted findings

FDA source excerpt, selected passage

Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Findings extracted from the letter

Selected FDA passages, not the complete letter.

Your firm failed to adequately test your OTC drug products prior to release and distribution to the U.S. market. For example, your firm did not perform assay testing of the API as part of finished product release testing of your **(b)(4)** product **(b)(4)** batches **(b)(4)**. These batches were released and distributed to the U.S. market without appropriate testing.

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Your firm failed to ensure components met United States Pharmacopeia (USP) monograph identity requirements and were suitable for use in manufacturing your **(b)(4)** drug products. For example:

You failed to test incoming lots of **(b)(4)** used in the manufacturing of the drug products intended for the US market for **(b)(4)** and **(b)(4)** in each shipment of each lot of **(b)(4)** before determining acceptability for use.

You failed to provide records indicating that you established the reliability of your supplier’s analyses through appropriate validation of the supplier’s test results. Although 21 CFR 211.84(d)(2) provides for some reliance on a COA from the supplier of the component, such reliance is permissible only if the drug product manufacturer establishes the reliability of the supplier’s test results through appropriate validation of the test results at appropriate intervals.

Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess (21 CFR 211.100(a)).

Your firm did not adequately validate the manufacturing processes you used to manufacture your **(b)(4)** drug products to demonstrate that your processes are reproducible and controlled to consistently yield drugs of uniform character and quality.

Sections and clauses cited

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 21021 CFR 211.165(a)21 CFR 211.84(d)(1)21 CFR 211.84(d)(2)21 CFR 211.100(a)21 CFR 211.22 21 CFR 211.188(b)21 CFR 211.166(a)

TCI Co., Ltd BioCosme PABP BRANCH

Findings and supporting evidence

Findings extracted from the letter

Sections and clauses cited

More drug letters

Keep exploring

Put this kind of reading to
work on your own records.

FDA Warning Letter Alerts

Findings and supporting evidence

Findings extracted from the letter

Sections and clauses cited

More drug letters

Keep exploring

Put this kind of reading towork on your own records.

Put this kind of reading to
work on your own records.