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