FDA 483 - Johnson Memorial Cancer Center - October 21, 2021

An FDA inspection of Johnson Memorial Cancer Center in Enfield, CT, a producer of sterile drug products, revealed critical deficiencies in aseptic processing. Observations included inadequate cleaning of work surfaces for hazardous drugs, failure to disinfect materials before entering aseptic areas, and deficient air pattern analyses for ISO 5 classified areas. Additionally, non-sterile disinfecting agents were used in critical aseptic processing environments, indicating a high risk of contamination.