Zhejiang Gaorong Cosmetic Co., Ltd. – FDA Warning Letter, Jan 20, 2026

The U.S. Food and Drug Administration (FDA) issued a warning letter dated October 1, 2026, to Zhejiang Gaorong Cosmetic Co., Ltd. following a review of records requested in January 2026. The review determined that the firm’s over-the-counter (OTC) drug manufacturing processes significantly violate Current Good Manufacturing Practice (CGMP) standards. Consequently, the company’s products are classified as adulterated under the Federal Food, Drug, and Cosmetic Act. Key violations include the failure to perform essential identity and purity testing on drug components. Most notably, the firm did not adequately screen high-risk ingredients for lethal contaminants such as diethylene glycol or ethylene glycol. Additionally, the company relied on supplier certificates of analysis without verifying their reliability. The FDA also identified a lack of oversight from the quality control unit, citing incomplete batch production records and insufficient stability data to support product expiration dates. Due to these safety concerns, the FDA placed the firm’s products on an import alert in July 2026. To resolve these issues, Zhejiang Gaorong Cosmetic Co., Ltd. must conduct a comprehensive risk assessment of products currently on the market, perform impurity testing on retained samples, and implement a plan to strengthen quality unit authority. The FDA also strongly recommends hiring a qualified third-party consultant to conduct a full audit of the facility’s manufacturing systems. Failure to address these deficiencies may result in continued refusal of entry for the company"s products into the United States.