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•Diego F. Montes, M.D.•October 6, 2025

FDA 483 - Diego F. Montes, M.D. - October 06, 2025

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Record Details

An FDA inspection of Medgate Life Sciences Group, Corp. in Pembroke Pines, FL, revealed significant deficiencies in the conduct of clinical investigations. Observations included failures to adhere to investigational plans and inclusion criteria, as well as issues with maintaining accurate case histories and informed consent forms. These findings indicate serious concerns regarding data integrity and subject protection in their clinical trials.

Company
Diego F. Montes, M.D.
Inspection Date
October 6, 2025
Product Type
Other
Office
Florida District Office
Person
  • Chantae D. Mitchell
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ID · db842fd6-f615-48f6-9020-ea706985d9fa

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