Warning Letter — Fresenius Kabi AG
The FDA issued a Warning Letter to Fresenius Kabi AG following an inspection by the Center for Drug Evaluation and Research (CDER). The specific details of the violations were not included in the provided excerpt but are documented under reference number 733107.
This notice affects Fresenius Kabi AG, specifically its drug manufacturing facilities, quality management personnel, and regulatory compliance departments.
A Warning Letter from CDER signifies that the agency has identified significant violations of current Good Manufacturing Practice (cGMP) regulations. This may lead to administrative actions, such as the withholding of new product approvals or import alerts, until the identified deficiencies are remediated and verified by the FDA.
Quality and Manufacturing teams should verify that current production controls align with validated parameters and ensure all equipment maintenance or process modifications are documented and reviewed for regulatory impact. Retrospective audits of batch records for potential deviations may be warranted.
FDA Warning Letter issued to: Fresenius Kabi AG. 09/22/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fresenius-kabi-ag-733107-09222026
Open in openFDA / FDA.gov