FDA WARNING_LETTER - Fresenius Kabi USA LLC - February 18, 2026

The FDA issued a warning letter to Fresenius Kabi USA LLC following an inspection of its Melrose Park, Illinois facility conducted between January 27 and February 18, 2026. The inspection identified significant violations of Current Good Manufacturing Practice (CGMP) regulations under the Federal Food, Drug, and Cosmetic Act, which led to the determination that several sterile injectable products were adulterated. Primary violations included the company’s failure to thoroughly investigate unexplained discrepancies and batch failures. Specifically, the firm ignored signals of contamination, such as endotoxin failures and the presence of biological matter like hair in finished products. The FDA also highlighted inadequate aseptic processing controls, citing failed media fills and poor cleanroom behavior by personnel. Additionally, the facility"s visual inspection program was deemed insufficient for detecting critical defects and particulates. To address these issues, the FDA requires Fresenius Kabi to provide comprehensive, independent assessments of its investigation systems, cleanroom practices, and visual inspection protocols. The company must also perform a retrospective review of all critical investigations from the past three years and develop a remediation plan for its quality control unit. The FDA recommended the engagement of a third-party consultant to assist in bringing the facility into compliance. Failure to take prompt corrective action could result in legal consequences, such as product seizures or the withholding of new drug approvals.