# FDA 483 - Fredric S. Brandt, M.D. - March 16, 2015

Source: https://www.globalkeysolutions.net/records/483/fredric-s-brandt-md/a9c105d8-6911-4863-8432-5793781587fd

> FDA 483 for Fredric S. Brandt, M.D. on March 16, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fredric S. Brandt, M.D.
- Inspection Date: 2015-03-16
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Fredric S. Brandt, M.D., a clinical investigator in Coral Gables, FL, revealed issues with incomplete records. Specifically, essential documentation for investigational device exposure and injection details was missing for multiple subjects during a clinical trial visit. This indicates a lapse in maintaining complete case histories for study participants.

## Related Officers

- [Dawn McCabe](https://www.globalkeysolutions.net/people/dawn-mccabe/48c5fe52-4cd6-4531-91c9-71dbe00b8bf2)

Company: https://www.globalkeysolutions.net/companies/fredric-s-brandt-md/137e83d8-8b95-4663-84b3-29bf5bc6ebb4

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