Warning Letter — IDO Pharm Co., Ltd.
The FDA issued a Warning Letter to IDO Pharm Co., Ltd. following an evaluation by the Center for Drug Evaluation and Research (CDER).
This affects IDO Pharm Co., Ltd. and its internal departments responsible for drug manufacturing, quality control, and regulatory compliance.
A Warning Letter from CDER indicates significant deviations from regulatory requirements, which may lead to enforcement actions such as the withholding of product approvals or import alerts. This suggests the firm's quality system may have failed to meet cGMP standards, requiring comprehensive remediation to maintain market access.
Review current manufacturing protocols against current Good Manufacturing Practice (cGMP) standards and prepare for potential import restrictions if remediation is required. Ensure all Quality Management System (QMS) documentation is audit-ready and reflects actual production floor practices.
FDA Warning Letter issued to: IDO Pharm Co., Ltd.. 05/04/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ido-pharm-co-ltd-723449-05042026
Open in openFDA / FDA.gov