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Talk to a SpecialistTalk to a SpecialistZhejiang Qimei Cosmetics Co., Ltd. manufactured sterile over-the-counter isopropyl alcohol prep pad drug products while failing to comply with Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The company's quality control unit did not effectively exercise its responsibility to ensure drug products met established specifications for identity, strength, quality, and purity as required under 21 CFR 211.22, resulting in adulterated drug products. FDA issued this warning based on records submitted in response to a March 2024 inspection request and identified significant CGMP violations in the company's manufacturing, processing, packing, and holding procedures.