FDA WARNING_LETTER - Foshan Miwei Cosmetics Co., Ltd. - October 24, 2025

The FDA issued a Warning Letter to Foshan Miwei Cosmetics Co., Ltd. following an inspection of its manufacturing facility in Guangdong, China, from October 20 to 24, 2025. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations and the Federal Food, Drug, and Cosmetic Act. Key violations included the failure to test finished drug products for strength and microbiological safety before distribution and the lack of identity testing for raw materials. The company also failed to verify the reliability of supplier reports or test for hazardous contaminants in high-risk ingredients. Furthermore, the firm lacked a stability testing program to support its product expiration dates and an adequate Quality Control Unit to oversee operations. The FDA also identified two products, Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer, as unapproved and misbranded new drugs. These products contained unauthorized active ingredients and featured misleading labeling regarding the function of certain components. As a result of these findings, the FDA placed the firm on an import alert in February 2026. Required actions include hiring an independent consultant to conduct a comprehensive audit, performing retrospective safety testing on products currently on the market, and establishing robust laboratory and quality oversight procedures. The company must provide a detailed remediation plan to the FDA within 15 days to avoid further regulatory action, such as continued refusal of product entry into the United States.