FDA Warning Letter to Foshan Miwei Cosmetics Co., Ltd. (April 20, 2026) — Nonprescription/OTC

FDA Warning Letter — Violations FDA cited at Foshan Miwei Cosmetics Co., Ltd.

WARNING LETTER Foshan Miwei Cosmetics Co., Ltd. MARCS-CMS 722272 — April 20, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Electronic Mail - Return Receipt Requested Reference #: 320-26-70 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Zhong Muqi Recipient Title Chief Executive Officer Foshan Miwei Cosmetics Co., Ltd. 801 & 802, Building 9, Baofa Jewellry Industry Centre No. 1 Feicui Road, Yang’e Village Committee, Lunjiao Town Shunde Qu Foshan Shi Guangdong Sheng , China Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-70 April 20, 2026 Dear Mr. Muqi: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Foshan Miwei Cosmetics Co., Ltd., FEI 3017118698, located at 801 & 802, Building 9, Baofa Jewellery Industry Centre, No. 1, Feicui Road, Yang’e Village Committee, Lunjiao Town, Shunde District, Foshan City, Guangdong Province, from October 20 to 24, 2025. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). In addition, Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) of the FD&C Act, 21 U.S.C. 331(d). Furthermore, Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer are misbranded under 502(a), 502(f)(1), and 502(ee) of the FD&C Act, 21 U.S.C. 352(a), (f)(1), and (ee). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below. We reviewed your November 7, 2025 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. During our inspection, our investigator observed specific violations including, but not limited to, the following. CGMP Violations 1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Your firm also failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)). Your firm manufactures over-the-counter (OTC) (b)(4) drug products. You did not test your drug products for the strength of each active ingredient prior to release and distribution. You also failed to conduct adequate microbiological testing for each batch of your OTC (b)(4) drug products. For example, your certificates of analysis (COAs) for (b)(4) batch (b)(4) and (b)(4) batch (b)(4) lacked active ingredient assay values and results for specified microorganisms. Full release testing, including for identity, strength, impurities, and microbiological limits, must be performed prior to drug product release and distribution. In response to this letter, provide: A list of chemical and microbial specifications, including test methods, used to analyze each batch of your drug products before a batch disposition decision. An action plan and timelines for conducti