FDA 483 - Jessica Kaffenberger, M.D. - March 13, 2020

An FDA inspection of Jessica Kaffenberger, M.D. in Gahanna, OH, a clinical investigator, revealed a significant issue regarding informed consent for pediatric subjects. The investigator failed to consistently obtain permission from both parents for children enrolled in a clinical investigation, as required by regulations. This deficiency was noted for both initial and reconsented subjects, with no documentation provided to explain the absence of a second parental signature.