Maria I. Bermudez, M.D.June 28, 2023

FDA 483 - Maria I. Bermudez, M.D. - June 28, 2023

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Maria I. Bermudez, M.D.

Record Details

An FDA inspection of Maria I. Bermudez, M.D., a clinical investigator in Miami, FL, revealed a significant deviation from the investigational plan. The firm failed to properly store serum samples, which experienced multiple temperature excursions, and incorrectly administered investigational product to a subject. These findings indicate a lack of adherence to study protocols and signed investigator statements.

Company: Maria I. Bermudez, M.D.
Inspection Date: June 28, 2023
Product Type: Drugs
Office: Office of Medical Device and Radiological Health Division II
Person: Richard A. Lyght

Open in Dashboard

ID · c2e1c0a7-7619-4926-80ef-590ee13ae77c