FDA 483 - Neil S. Sadick, M.D. - October 09, 2024

An FDA inspection of Neil S. Sadick, M.D. (Sadick Anesthetic Surgery & Dermatology) in New York, NY, revealed that an investigation was not conducted in accordance with the signed statement of investigator and investigational plan. The firm failed to re-consent subjects after protocol amendments that altered study design or increased potential risk, and did not ensure documented medical histories were available to verify inclusion and exclusion criteria for some participants. These findings indicate significant deviations from established clinical trial protocols and subject protection requirements.