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

Source: https://www.globalkeysolutions.net/records/483/momentis-surgical-ltd/e3e55668-ed23-489b-ad0b-85fe85605031

> FDA 483 for Momentis Surgical Ltd. on July 01, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Momentis Surgical Ltd.
- Inspection Date: 2022-07-01
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Esteban Beltran](https://www.globalkeysolutions.net/people/esteban-beltran/9a9bf6b2-ecdf-494c-82f4-5ef5932d629a)

Company: https://www.globalkeysolutions.net/companies/momentis-surgical-ltd/10e763be-2670-4d36-9588-b3cd8a7f23aa

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd