Yahon Enterprise Co., Ltd.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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)).

Passage 2

Your firm failed to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(2)).

Passage 3

You failed to perform adequate identity testing on each lot of ethyl alcohol and benzylkonium chloride used to manufacture your OTC drug products. Because you did not perform adequate identity testing on each shipment of each lot, you failed to assure the acceptability of these components for use in the manufacture of your drug products.

Passage 4

Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).