Huangshi Hygienic Material Medicine 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 perform appropriate testing on your drug products prior to release for distribution. Your facility management stated to our investigator that testing for identity and strength of each active ingredient prior to release had not been performed for approximately **(b)(4)** batches manufactured for the U.S. market.

Passage 3

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)).

Passage 4

Your firm failed to establish an adequate stability program and lacked chemical and microbial testing data to demonstrate that your over-the-counter (OTC) drug products will remain acceptable throughout their assigned expiry period.