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483
•Elizabeth Mones, M.D.•July 3, 2024

Elizabeth Mones, M.D. – FDA 483, Jul 3, 2024

Record Details

The FDA inspected Health Care Family Rehab And Research Center in Hialeah, FL, a clinical investigator, and found two significant issues. The firm failed to conduct an investigation according to the protocol by not discontinuing a subject who experienced an adverse event. Additionally, the firm failed to maintain adequate and accurate case histories, as medical records were not attributable to specific subjects and MRI/CT scan reports were altered and sometimes illegible.

Company
Elizabeth Mones, M.D.
Inspection date
July 3, 2024
Product type
drugs
Office
Office of Medical Device and Radiological Health Division II
People
  • Chantae D. Mitchell
  • Hugh M. McClure III
View Company Profile

ID · 3050195e-aeed-44c2-a2f3-d2fb3a2cae13

Other documents for Elizabeth Mones, M.D.
  • EIR - 2024-07-03July 3, 2024

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