# FDA 483 - Insightec, Inc - March 28, 2025

Source: https://www.globalkeysolutions.net/records/483/insightec-inc/b217ab2b-818f-4ba5-8c6c-aa20b9fe364a

> FDA 483 for Insightec, Inc on March 28, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Insightec, Inc
- Inspection Date: 2025-03-28
- Product Type: other
- Office Name: Dallas District Office
- Summary: An FDA inspection of Insightec, Inc. in Dallas, TX, revealed significant deficiencies in the conduct of an investigational study. The firm failed to ensure proper monitoring of clinical research sites, leading to delayed monitoring reports. Additionally, the sponsor did not ensure that reviewing Institutional Review Boards (IRBs) were promptly informed of new safety information concerning study participants.

## Related Officers

- [Andrace Deyampert](https://www.globalkeysolutions.net/people/andrace-deyampert/cdb4f833-488b-42b9-abab-4216435bce4c)
- [Terri E. Gibson](https://www.globalkeysolutions.net/people/terri-e-gibson/f1a80f95-a5c4-4cae-9a4b-e23f367770bb)

Company: https://www.globalkeysolutions.net/companies/insightec-inc/cd0e780d-2706-4d95-9a3a-962e6ede3cae

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9