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Talk to a SpecialistTalk to a SpecialistZhejiang Uniquality Nursing Products Technology Co., Ltd., a manufacturer of over-the-counter drug products, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their products adulterated. The company failed to adequately test components for identity and conformity with specifications for purity, strength, and quality, and did not validate or establish the reliability of their component suppliers' test analyses at appropriate intervals, as required under 21 CFR 211.84(d)(1) and (2). These violations were identified following FDA's review of records submitted in response to March and April 2024 information requests.