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FDA Warning Letter Explorer
Drugs · Nov 12, 2024

Zhejiang Uniquality Nursing Products Technology Co., Ltd. dba ZheJiang YouQuan Care Products Technology Co., Ltd.

4 extracted findings

FDA source excerpt, selected passage

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)).

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.

01
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)).
02
Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
03
Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).
04
Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Zhejiang Uniquality Nursing Products Technology Co., Ltd., at No. 68 Luhui Road, Taihu Street, Changxing County, Huzhou, Zhejiang 313100, 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.

Sections and clauses cited

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

21 CFR 211.84(d)(1)21 CFR 211.160(b)21 CFR 211.22(a)

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