# FDA WARNING_LETTER - Zhejiang Qimei Cosmetics Co., Ltd. - November 07, 2024

Source: https://www.keypedia.com/records/warning_letter/zhejiang-qimei-cosmetics-co-ltd/07a81a24-7787-4b92-aca2-cc9d107cd99a

> FDA WARNING_LETTER for Zhejiang Qimei Cosmetics Co., Ltd. on November 07, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Zhejiang Qimei Cosmetics Co., Ltd.
- Inspection Date: 2024-11-07
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Zhejiang Qimei Cosmetics Co., Ltd. (FEI 3018321301) on November 7, 2024, following a review of records submitted per section 704(a)(4) of the FD&C Act. The facility, an OTC drug product manufacturer, was found to have significant Current Good Manufacturing Practice (CGMP) violations, rendering its drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include:
1.  **Failure of Quality Control Unit (QCU) Responsibilities (21 CFR 211.22):** The QCU did not ensure OTC isopropyl alcohol (IPA) prep pads, labeled as sterile, were rendered sterile by an appropriate manufacturing process.
2.  **Inadequate Finished Product Testing (21 CFR 211.165(a)):** The firm failed to adequately test OTC IPA prep pads for identity and strength of IPA prior to release.
3.  **Insufficient Component Testing (21 CFR 211.84(d)(1)):** The firm did not adequately test incoming glycerin and propylene glycol for diethylene glycol/ethylene glycol limits, or ethanol and IPA for methanol limits, which are high-risk impurities.

The FDA recommends engaging a qualified CGMP consultant to evaluate operations and perform

## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

Company: https://www.keypedia.com/companies/zhejiang-qimei-cosmetics-co-ltd/b8e0c2f2-5b5c-4778-b423-77373bc4e0f4

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c