FDA 483 - Amer M. Zeidan, M.D. - August 08, 2025

Amer M. Zeidan, M.D. in New Haven, CT, a clinical investigator, was issued a Form FDA 483 following an inspection. The inspection revealed a failure to maintain accurate case histories for a clinical study. Specifically, data points from bone marrow pathology reports were incorrectly entered into the electronic data capture system.