FDA 483 - Rajinder S. Shiwach, M.D. - June 11, 2025

An FDA inspection of Rajinder S. Shiwach, M.D. (Insite Clinical Research) in Desoto, TX, revealed significant deficiencies in clinical study conduct. Observations included failure to ensure proper IRB review and approval for a "guesting" process, as well as enrolling ineligible subjects and failing to discontinue treatment for subjects meeting discontinuation criteria. These findings indicate serious non-compliance with regulatory requirements for clinical investigations.