FDA 483 - Fresenius Kabi USA, LLC - February 13, 2026

Fresenius Kabi USA, LLC, a sterile drug manufacturer in Wilson, NC, was cited for significant deficiencies across multiple quality system areas during an FDA inspection. Observations included failures in preventing microbiological contamination of sterile products, inadequate equipment cleaning and maintenance, and a systemic failure to thoroughly investigate discrepancies and batch failures. The firm also demonstrated deficiencies in quality control unit procedures, complaint handling, and maintaining segregated areas to prevent mix-ups.