FDA 483 - Jack Michael Mann, M.D. - December 06, 2022

An FDA inspection of Jack Michael Mann, M.D. in Bayside, NY, a clinical investigator, revealed a significant issue with the conduct of an investigation. The firm failed to follow the signed statement of investigator and investigational plan, specifically regarding subject randomization and drug dosing. This resulted in a subject receiving an incorrect, higher dose of medication due to an error in weight scale conversion.