Carlos M. Martinez, M.D.November 1, 2022

FDA 483 - Carlos M. Martinez, M.D. - November 01, 2022

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Record Details

An FDA inspection of Carlos M. Martinez, M.D. in Cutler Bay, FL, a clinical investigator, revealed a significant deviation from investigational plans. The firm failed to conduct investigations in accordance with the signed statement of investigator and investigational plan. Specifically, study staff instructed subjects to change e-diary PIN codes for daily dosing and symptom data, bypassing the required helpdesk contact.

Company: Carlos M. Martinez, M.D.
Inspection Date: November 1, 2022
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Division II
People: Douglas Florentino
Richard A. Lyght

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