FDA 483 - Sterigenics Germany GmbH - May 15, 2024

An FDA inspection of Sterigenics Germany GmbH, a contract sterilizer of medical devices in Wiesbaden, Germany, revealed a significant concern regarding their equipment calibration procedures. The firm failed to adequately evaluate the potential adverse effects on processed medical devices after a temperature block calibrator, critical for sterilizer chamber temperature probes, failed calibration. This indicates a potential risk to the quality and sterility of medical devices processed by the firm.