# FDA 483 - Gregory A. Guell, M.D. - October 31, 2022

Source: https://www.globalkeysolutions.net/records/483/gregory-a-guell-md/792717c5-ab64-4527-9fd4-4b0103b0398f

> FDA 483 for Gregory A. Guell, M.D. on October 31, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gregory A. Guell, M.D.
- Inspection Date: 2022-10-31
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Suncoast Research Group Llc in Miami, FL, revealed significant deficiencies in maintaining accurate case histories for a clinical study. The firm failed to report adverse events, accurately document AE start and end dates, record new concomitant medications, and ensure proper investigational product accountability and compliance. These issues indicate a serious lack of adherence to clinical trial record-keeping standards.

## Related Officers

- [Angelica M. Chica](https://www.globalkeysolutions.net/people/angelica-m-chica/117a5aa3-e5ed-46f2-bf32-885591c34848)

Company: https://www.globalkeysolutions.net/companies/gregory-a-guell-md/dbaa200b-2154-41c1-aa7b-3f7eb65fcf15

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