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•Ivan Carreras, M.D.•August 23, 2024

FDA 483 - Ivan Carreras, M.D. - August 23, 2024

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Record Details

An FDA inspection of Ivan Carreras M.D./Clintex Research Group, Inc. in Miami, FL, identified a significant issue regarding the retention of investigational product samples. The firm failed to retain the required quantities of test article and reference standard samples for a bioequivalence study, specifically for two shipments. This indicates a deficiency in adherence to regulatory requirements for sample retention.

Company
Ivan Carreras, M.D.
Inspection Date
August 23, 2024
Product Type
Drugs
Office
Office of Medical Device and Radiological Health Division II
Person
  • Chantae D. Mitchell
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ID · a0388942-1232-475f-98d5-f517f74f95a7

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