FDA 483 - Fresenius Kabi USA, LLC - May 14, 2026

Fresenius Kabi USA, LLC, a sterile drug manufacturer in Grand Island, NY, was cited for significant deficiencies in its quality control systems. Observations included inadequate procedures for production and process controls, particularly concerning visual inspection of sterile vials, and insufficient validation of aseptic and sterilization processes. Additionally, the firm failed to perform comparative testing for analytical method transfers under actual conditions of use.