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

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.