JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. – FDA Warning Letter, Nov 7, 2025

This FDA warning letter, issued on September 23, 2026, details significant manufacturing violations at Jiangmen Shuizirun Sanitary Articles Co., Ltd. in Guangdong, China. During an inspection conducted from November 3 to 7, 2025, the FDA found that the company"s over-the-counter drug products failed to meet Current Good Manufacturing Practice (CGMP) standards, rendering them adulterated under the Federal Food, Drug, and Cosmetic Act. The primary violations include marketing products as "sterile" despite the absence of sterilization processes or sterility testing. The firm also failed to conduct essential identity and purity tests on raw materials. Most critically, they did not screen high-risk components for hazardous contaminants such as diethylene glycol and ethylene glycol, which have historically caused lethal poisonings. Additionally, the company’s quality control unit was found to have insufficient oversight, resulting in improper batch numbering and unvalidated manufacturing processes. In response, the FDA has placed the company on an import alert, effectively blocking its products from entering the United States. Required actions include initiating a recall of all products falsely labeled as sterile, performing a comprehensive risk assessment of all drug components, and hiring an independent consultant to overhaul the facility’s quality systems. The company must submit a formal remediation plan within 15 business days to address these safety and compliance failures.