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

Source: https://www.keypedia.com/records/483/gregory-a-guell-md/366b1308-9116-4f13-b1ca-cc8e74b67eb0

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

---

## Details

- Record Type: 483
- Company Name: Gregory A. Guell, M.D.
- Inspection Date: 2022-10-31
- Product Type: drugs
- Office Name: Florida District Office
- Summary: An FDA inspection of Gregory A. Guell, M.D. (Suncoast Research Group Llc) was conducted from October 19 to October 31, 2022, focusing on the firm's conduct of a specific clinical study protocol. The inspection resulted in observations documented on a Form FDA 483, primarily citing a failure to prepare or maintain accurate case histories concerning observations and data critical to the investigation. Key issues identified included lapses in Adverse Event (AE) reporting, where clinically significant lab abnormalities for two subjects were not reported to the electronic case report form (eCRF) or the study sponsor. Additionally, inaccurate start and/or end dates for reported AEs were noted for two subjects, and one subject's new concomitant medication was not properly documented or reported. A significant concern involved Investigational Product (IP) accountability and compliance, with nine out of ten reviewed subjects demonstrating inaccurate documentation in their source records regarding medication dispensed and returned. These findings reflect a need for improved adherence to regulatory standards for clinical investigation data integrity and record management. The firm is expected to respond to these observations with corrective actions to ensure future compliance.

## Related Documents

- [483 - 2022-10-31](https://www.keypedia.com/records/483/gregory-a-guell-md/792717c5-ab64-4527-9fd4-4b0103b0398f)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9