Fredric S. Brandt, M.D.March 16, 2015

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

Record Details

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.

Company: Fredric S. Brandt, M.D.
Inspection Date: March 16, 2015
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Division II
Person: Dawn McCabe

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ID · a9c105d8-6911-4863-8432-5793781587fd