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

Source: https://www.keypedia.com/records/483/carlos-m-martinez-md/5ba745f6-6188-4633-9682-b5aeb01ae8fb

> FDA 483 for Carlos M. Martinez, M.D. on November 01, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Carlos M. Martinez, M.D.
- Inspection Date: 2022-11-01
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

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Company: https://www.keypedia.com/companies/carlos-m-martinez-md/65995f50-4a23-4753-8fa9-c18fb67ba255

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