FDA 483 - Eric Jonasch, M.D. - March 05, 2021

An FDA inspection of clinical investigator Eric Jonasch, M.D. in Houston, TX, from February 24 to March 5, 2021, revealed significant deficiencies in maintaining adequate and accurate case histories. The observations included failures in contemporaneously reporting source data for study subjects and a lack of documentation regarding birth control methods. These issues highlight concerns with data integrity and adherence to proper record-keeping practices in clinical investigations.