# FDA 483 - InSightec, Ltd. - November 30, 2017

Source: https://www.keypedia.com/records/483/insightec-ltd/710b939e-448c-4a8d-a00d-9d8319e69724

> FDA 483 for InSightec, Ltd. on November 30, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: InSightec, Ltd.
- Inspection Date: 2017-11-30
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: InSightec, Ltd., a medical device manufacturer in Tirat Carmel, Hefa, Israel, received two observations during an FDA inspection. The firm's medical device reporting (MDR) procedure was found to be inadequate, leading to a failure to report two serious injury events. Additionally, their corrective and preventive action (CAPA) procedures were not adequately established, specifically lacking verification of effectiveness.

## Related Documents

- [483 - 2017-11-27](https://www.keypedia.com/records/483/insightec-ltd/d2dd76bf-43b5-4530-8609-8f0a5c0955c3)

## Related Officers

- [Medical Device Specialist](https://www.keypedia.com/people/rosanna-m-goodrich/44c5c743-f67b-41fe-9cd1-8b5913bf580e)
- [Investigative Engineer ](https://www.keypedia.com/people/leonard-h-lavi/afe5082f-67e5-4bf2-a981-022756e93eb4)

Company: https://www.keypedia.com/companies/insightec-ltd/ec1c2995-70ff-4ab7-85d7-c3d409aed07a

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