FDA 483 - Amitabha Mazumder, M.D. - April 05, 2024

The FDA inspected Clinical Investigator Amitabha (NMI) Mazumder in Pasadena, CA, and issued a Form 483 for significant deviations from an investigational plan. Observations included failures to perform required hematocrit level assessments, administer study drug without prior testing, administer protocol-prohibited medication, and properly assess patient reported outcomes. These findings indicate serious non-compliance with the study protocol.