> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CGMP Violations in Zhejiang Qimei Records Review
- URL: https://www.fdaweb.com/cgmp-violations-in-zhejiang-qimei-records-review/
- Published: 2024-11-12T12:00:00.000Z
- Updated: 2026-09-14T14:46:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158163

An FDA review of records submitted at the agency’s request by the over-the-counter drug producer Zhejiang Qimei Cosmetics Co. in Zhejiang Sheng, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 11/7 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zhejiang-qimei-cosmetics-co-ltd-690950-11072024?ref=fdaweb.com) says specific violations were:

- failure of the firm’s quality control unit to exercise its responsibility to ensure drug products that are manufactured comply with CGMP, and meet established specifications for identity, strength, quality, and purity;
- failure 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; and
- failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality.

FDA recommends that the firm engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. Zhejiang was placed on an Import Alert on 11/7.

The company was told to correct violations promptly and to respond with a list of specific actions it has taken to address violations and prevent their recurrence, with a schedule for completing the corrections.