FDA 483 - Sentara Infusion Services - December 16, 2022

An FDA inspection of Sentara Infusion Services in Chesapeake, VA, a producer of sterile drug products, revealed significant deficiencies in aseptic processing. The firm was cited for using non-sterile cleaning materials, inadequate disinfection practices, and failing to address persistent microbial contamination in classified areas. Additionally, issues included poor personnel gowning and aseptic technique, cross-contamination risks, and insufficient environmental monitoring and facility certification, indicating a high risk to sterile product integrity.