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# CGMP Violations at Zhejiang Uniquality
- URL: https://www.fdaweb.com/cgmp-violations-at-zhejiang-uniquality/
- Published: 2024-12-03T12:00:00.000Z
- Updated: 2026-09-14T14:48:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158286

An FDA review of records submitted by Zhejiang Uniquality Nursing Products Technology Co., Ltd., doing business as Zhejiang YouQuan Care Products in Zhejiang Sheng, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 11/12 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zhejiang-uniquality-nursing-products-technology-co-ltd-dba-zhejiang-youquan-care-products-technology?ref=fdaweb.com) says specific violations were:

- failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
- failure 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; and
- failure 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.

FDA recommends that the firm engage a qualified consultant to perform a six-system audit of its entire operation for CGMP compliance, assist it in meeting CGMP requirements, and evaluate the completion and efficacy of its corrective and preventive actions before Zhejiang pursues resolution of its compliance status with FDA. The agency placed the company on an import alert on 11/12.

Zhejiang 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.