# FDA 483 - Brava, LLC - March 14, 2014

Source: https://www.keypedia.com/records/483/brava-llc/b5490bb7-a2a1-4ec7-a23a-6943ce087386

> FDA 483 for Brava, LLC on March 14, 2014. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brava, LLC
- Inspection Date: 2014-03-14
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Brava, LLC, a medical device sponsor/monitor in Miami, FL, was cited for significant deficiencies in its conduct of a clinical investigation for the Brava AFT System. The inspection revealed failures in meeting investigational device exemption (IDE) requirements, including issues with informed consent, IRB communication, investigator monitoring, financial disclosures, and adherence to cGMPs and QSR. These observations indicate a serious lack of oversight and compliance in clinical study management.

## Related Documents

- [WARNING_LETTER - 2014-03-14](https://www.keypedia.com/records/warning_letter/brava-llc/719f0e52-9802-4cb2-a446-1b94e09af59a)

## Related Officers

- [Dianiris C. Ayala](https://www.keypedia.com/people/dianiris-c-ayala/ba6c5538-201b-4c9a-8f23-e160db6868e6)

Company: https://www.keypedia.com/companies/brava-llc/6771295f-377e-47b8-a0ad-201da75d5b17

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6