Momentis Surgical Ltd.July 1, 2022

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

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Record Details

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.

Company: Momentis Surgical Ltd.
Inspection Date: July 1, 2022
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Esteban Beltran

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