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Imperial Palace Commodity (Dongguan) Co., Ltd., an OTC drug manufacturer including alcohol wipes, failed to adequately test incoming components for identity, purity, strength, and quality, and did not validate or establish the reliability of its component suppliers' test analyses at appropriate intervals, violating 21 CFR 211.84(d)(1) and (d)(2). These Current Good Manufacturing Practice (CGMP) violations resulted in the company's drug products being deemed adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. The FDA issued this warning letter on January 27, 2025, following the company's response to a March 4, 2024 records request and subsequent inquiries.