FDA 483 - Manohar L. Jethani, MD - February 05, 2026

Manohar L. Jethani, MD, a clinical investigator in Oak Brook, IL, was cited for two significant issues during an FDA inspection. The firm failed to conduct an investigation in accordance with the signed statement of investigator and investigational plan, specifically regarding laboratory testing procedures and sample collection. Additionally, the firm did not obtain informed consent from human subjects prior to initiating study-related screening procedures, violating federal regulations.