Zhejiang Qimei Cosmetics 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 identity and conformity with all appropriate written specifications for purity, strength, and quality. (21 CFR 211.84(d)(1)).

Passage 3

Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Zhejiang Qimei Cosmetics Co., Ltd., 3018321301, at No. 518 ChuangYe Road, Chongfu Town, TongXiang City, Jiaxing, Zhejiang 314511, China, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission.