# FDA 483 - Icecure Medical Ltd - March 22, 2023

Source: https://www.keypedia.com/records/483/icecure-medical-ltd/ccdc03fe-4860-401d-a444-2cf2e4e2f3c0

> FDA 483 for Icecure Medical Ltd on March 22, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Icecure Medical Ltd
- Inspection Date: 2023-03-22
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

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

Company: https://www.keypedia.com/companies/icecure-medical-ltd/1cac3851-1d00-4fd1-a798-073f6796e273

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