FDA 483 - Kwabena Ntoso M.D - October 11, 2023

An FDA inspection of Kwabena Ntoso M.D, a clinical investigator site in Philadelphia, PA, revealed significant deficiencies in record-keeping practices. The site failed to maintain adequate study source records for a majority of screened subjects and did not retain signed informed consent forms. Additionally, required investigation records were not retained for the specified two-year period.