FDA 483 - Kimball A. Johnson, M.D. - May 21, 2026

An FDA inspection of Kimball A. Johnson, M.D. in Decatur, GA, a clinical investigator, revealed a significant protocol deviation. The firm failed to conduct an investigation in accordance with the signed statement of investigator and investigational plan, resulting in three out of four enrolled subjects receiving investigational product doses exceeding protocol-allowed limits and experiencing adverse events.