FDA WARNING_LETTER - Zhejiang Easyclean Daily Chemical Co., Ltd - June 03, 2025

The FDA issued a Warning Letter to Zhejiang Easyclean Daily Chemical Co., Ltd, a Chinese manufacturer of over-the-counter (OTC) drug products, following a review of records submitted in response to a 704(a)(4) request. The letter, dated May 14, 2025, identifies significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). Key deficiencies include the firm's failure to perform adequate finished drug product testing for active ingredient identity and strength prior to release (21 CFR 211.165(a)), and to establish an adequate stability testing program with long-term data and active ingredient testing to determine appropriate expiration dates (21 CFR 211.166(a)). Furthermore, the firm failed to prepare complete batch production and control records (21 CFR 211.188) and lacked adequate written procedures for production and process control, including performing no process validation activities (21 CFR 211.100(a)). The FDA recommends engaging a qualified CGMP consultant to conduct a comprehensive six-system audit and evaluate corrective actions. The firm must respond within 15 working days detailing corrective actions and prevention strategies. Failure to address these violations may result in FDA withholding new drug approvals and refusing admission of products into the U.S.