FDA 483 - Peter Karachunski, M.D. - January 16, 2025

This FDA Form 483 was issued to Peter I. Karachunski, M.D., a clinical investigator in Minneapolis, MN, following an inspection from January 6-16, 2025. The inspection revealed a significant deficiency in maintaining adequate and accurate case histories, specifically concerning the documentation of adverse events in electronic case report forms (eCRFs) as required by protocol. This indicates a failure to ensure complete and accurate data recording in clinical investigations.