Warning Letter — Jiangmen Shuizirun Sanitary Articles Co., Ltd.
The FDA Center for Drug Evaluation and Research (CDER) issued a Warning Letter to Jiangmen Shuizirun Sanitary Articles Co., Ltd. following an evaluation of the firm's compliance with regulatory standards.
Jiangmen Shuizirun Sanitary Articles Co., Ltd., specifically their manufacturing and quality units, as well as entities importing their sanitary or drug products into the U.S. market.
This action indicates significant deviations from cGMP requirements that led to formal enforcement by CDER. While the specific violations are not detailed in the provided excerpt, such letters typically result in import alerts or the withholding of drug approvals until the firm demonstrates corrective actions. Regulatory teams should view this as a signal of heightened scrutiny for international manufacturers of sanitary and OTC products.
Review current Good Manufacturing Practice (cGMP) compliance for sanitary and topical drug products. Ensure all drug products manufactured for the U.S. market adhere to CDER regulatory requirements regarding production and quality control.
FDA Warning Letter issued to: Jiangmen Shuizirun Sanitary Articles Co., Ltd.. 09/23/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jiangmen-shuizirun-sanitary-articles-co-ltd-722974-09232026
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