Zhejiang Uniquality Nursing Products Technology Co., Ltd. dba ZheJiang YouQuan Care Products Technology Co., Ltd. – FDA Warning Letter, Dec 3, 2024

On November 12, 2024, the FDA issued a Warning Letter to Zhejiang Uniquality Nursing Products Technology Co., Ltd. (FEI 3012557963), a manufacturer of OTC drug products in China. The letter followed a review of records submitted in response to March 11 and April 15, 2024, requests under section 704(a)(4) of the FD&C Act.

The FDA identified significant Current Good Manufacturing Practice (CGMP) violations, rendering the firm's drug products adulterated under section 501(a)(2)(B) of the FD&C Act. Violations included:

1. **Failure to test components for identity and conformity (21 CFR 211.84(d)(1) and 211.84(d)(2)):** The firm did not adequately test incoming raw materials, including identity testing, and relied on supplier Certificates of Analysis (COAs) without validating their reliability. Specifically, the firm failed to test each shipment of (b)(4) and (b)(4) for identity, including limit tests for (b)(4) or (b)(4) contamination, and did not demonstrate suitability of (b)(4) for use. 2. **Failure to establish adequate laboratory controls (21 CFR 211.160(