FDA 483 - Isomedix Operations Inc.

Isomedix Operations Inc in Minneapolis, MN, was inspected by the FDA from September 13-15, 2023, and received a Form 483 with three observations. The inspection revealed deficiencies including a lack of designated quarantine areas for products, inadequate documentation of alarms from sterilization chamber software, and poor trackability and traceability for biological indicators and data loggers used in ethylene oxide sterilization cycles. These issues indicate significant concerns regarding contamination prevention, aseptic processing controls, and quality control unit procedures.