Warning Letter — Sato Pharmaceutical Co., Ltd.
The FDA issued a Warning Letter to Sato Pharmaceutical Co., Ltd. following an evaluation by the Center for Drug Evaluation and Research (CDER).
Sato Pharmaceutical Co., Ltd., its manufacturing leadership, quality control units, and regulatory compliance teams associated with drug production for the U.S. market.
The issuance of a Warning Letter by CDER indicates that the firm's prior responses to inspectional observations were likely insufficient to address underlying compliance risks. This may lead to import alerts, withholding of product approvals, or further enforcement actions if remedial steps are not documented and verified.
Firms should conduct a comprehensive internal audit of manufacturing practices against current Good Manufacturing Practice (cGMP) standards and ensure all facility responses to FDA observations are robust, timely, and evidence-based.
FDA Warning Letter issued to: Sato Pharmaceutical Co., Ltd.. 05/18/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sato-pharmaceutical-co-ltd-723059-05182026
Open in openFDA / FDA.gov