# FDA 483 - Jennifer W. Leiding M.D. - September 08, 2023

Source: https://www.keypedia.com/records/483/jennifer-w-leiding-md/00fff4fe-adea-4dcd-b7fb-bce202767515

> FDA 483 for Jennifer W. Leiding M.D. on September 08, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Jennifer W. Leiding M.D.
- Inspection Date: 2023-09-08
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Jennifer W. Leiding, Clinical Investigator, in Seminole, FL, revealed significant deficiencies in the conduct of a clinical study. Observations included failures to obtain proper informed consent, report non-serious adverse events to the sponsor, and maintain accurate case histories by reporting all concomitant medications. These issues indicate a concerning lack of adherence to regulatory requirements for human subject protection and data integrity in clinical trials.

## Related Officers

- [Angelica M. Chica](https://www.keypedia.com/people/angelica-m-chica/117a5aa3-e5ed-46f2-bf32-885591c34848)
- [Valerie L Kelesyan](https://www.keypedia.com/people/valerie-l-kelesyan/4aab1ed0-6e73-404b-864c-15fe435f4722)

Company: https://www.keypedia.com/companies/jennifer-w-leiding-md/98edc455-4c66-4350-91b4-ad8aeaf33c26

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