FDA Issues Warning Letter to Foshan Miwei Cosmetics

Foshan Miwei Cosmetics Co., Ltd.—a company that focuses on the manufacturing and trade of organic and natural skin care products that are often sold on Amazon—received a warning letter from the United States Food and Drug Administration (FDA) for violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.

The FDA inspected the drug manufacturing facility in China from Oct. 20-24, 2025.

FDA Letter Highlights

According to the FDA letter: “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.”

Inspection Details

During the FDA inspection, the investigator observed “specific violations including, but not limited to,” the following.

“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 failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals. Your firm also failed to conduct microbiological testing before use of each lot of a component with potential for objectionable microbiological contamination in light of its intended use (21 CFR 211.84(d)(1) and 211.84(d)(2)) and (21 CFR 211.84(d)(6)).

“Your firm failed to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

“Your firm failed to establish written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22(d)).”

Unapproved New Drugs & Misbranded Drug Violations

Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer products are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body.

Based on the above labeling evidence, Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer are drug products intended for use as over-the-counter (OTC) sunscreen drug products. These OTC drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).

Read the full letter here.