FDA WARNING_LETTER - Foshan Yiying Hygiene Products Co., Ltd. - February 10, 2025

On October 10, 2025, the FDA issued a Warning Letter to Foshan Yiying Hygiene Products Co., Ltd., an over-the-counter (OTC) drug product manufacturer. This letter resulted from a review of company records submitted to the FDA, which revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.

The main issues identified include the company"s failure to adequately test finished drug products for identity and strength before release, and a lack of appropriate stability testing to support assigned expiration dates. The firm also failed to test incoming raw materials for identity, notably not testing for dangerous contaminants like diethylene glycol in glycerin. Furthermore, Foshan Yiying Hygiene Products lacked adequate written procedures for production and process control, specifically failing to validate manufacturing processes, and did not maintain complete batch production records. These failures indicate the company cannot ensure the quality, purity, and strength of its drug products, classifying them as adulterated under federal law.

As a required action, the FDA strongly advised Foshan Yiying Hygiene Products to engage a qualified CGMP consultant. This consultant must evaluate the company"s entire operations, help implement corrective and preventive actions, and conduct a comprehensive audit to ensure compliance before seeking resolution with the FDA.