FDA 483 - Momentis Surgical Ltd. - July 01, 2022

Momentis Surgical Ltd. in Or Yehuda, Tel Aviv, Israel, was inspected by the FDA from June 27 to July 1, 2022. The inspection revealed one observation concerning the lack of documented process validation activities for the ETO sterilization of its Hominis Surgical System arms. This indicates a deficiency in ensuring the effectiveness of critical sterilization processes.