483
Matthew A. Cunningham, M.D.FDA 483 - Matthew A. Cunningham, M.D. - April 18, 2025
Discuss this record with AI
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.
Record Details
An FDA inspection of Florida Retina Institute, a clinical investigator in Orlando, FL, revealed significant deficiencies in the conduct of a clinical investigation. Observations included failures to follow the investigational plan, improper documentation of informed consent, and inadequate maintenance of case histories. These issues indicate a lack of adherence to regulatory requirements for clinical trials.
Open in Dashboard
ID · fd942fb8-e69a-492e-bb2f-e241af692bb1