FDA 483 - Dipakkumar P. Pandya, M.D. - February 01, 2024

An FDA inspection of Dipakkumar P. Pandya, M.D. in Annandale, NJ, revealed significant deviations from clinical study protocols and inadequate record-keeping. The firm failed to conduct required safety assessments, monitor investigational product storage, and maintain complete and correct informed consent forms and subject data. These issues indicate a lack of adherence to good clinical practice during the study.