Rishi K. Wadhwa, M.D. – FDA 483, Mar 20, 2026

An FDA inspection of Rishi K. Wadhwa, M.D. in Shreveport, LA, a clinical investigator for cervical disc prosthesis trials, revealed significant deficiencies in the conduct of investigations. Observations included improper subject randomization, incomplete and inaccurate subject records, and failures in adverse event reporting and documentation. These issues indicate a lack of adherence to investigational plans and applicable FDA regulations, compromising data integrity and subject safety.