FDA 483 - Konrad Rejdak, M.D. - May 19, 2023

An FDA inspection of Konrad Rejdak, M.D., a clinical investigator in Lublin, Poland, revealed a significant issue regarding the maintenance of adequate and accurate case histories. The firm failed to ensure source data was available for several subjects' adjusted data, which was not directly recorded as required by their study protocol. This indicates a deficiency in data integrity and record-keeping practices during a clinical investigation.