Icecure Medical Ltd – FDA 483, Mar 22, 2023

Icecure Medical Ltd, a manufacturer in Caesarea, Israel, was inspected and cited for significant deficiencies related to medical device reporting and process validation. The firm failed to submit required Medical Device Reports (MDRs) for device malfunctions and lacked an adequate written procedure for timely MDR submission. Additionally, critical manufacturing processes, including sterilization packaging and shelf-life studies for CryoProbes, were not properly validated.