Warning Letter — Sourav K. Mishra, M.D. / All India Institute of Medical Sciences
The FDA issued a warning letter to Dr. Sourav K. Mishra at the All India Institute of Medical Sciences following an inspection that identified non-compliance with clinical investigator requirements.
Clinical investigators, trial sponsors conducting international research under FDA jurisdiction, and clinical operations teams.
This enforcement action against an international investigator suggests that the FDA is maintaining active oversight of global clinical trial sites to ensure data integrity and subject safety. Regulatory teams may view this as a reminder that non-US sites are subject to the same rigorous compliance standards as domestic investigators when contributing data to US marketing applications.
Clinical trial sponsors should evaluate the investigator oversight protocols at international sites and ensure that site staff are adhering strictly to the investigational plan and FDA reporting requirements for clinical trials under IND.
FDA Warning Letter issued to: Sourav K. Mishra, M.D. / All India Institute of Medical Sciences. 04/29/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sourav-k-mishra-md-all-india-institute-medical-sciences-724881-04292026
Open in openFDA / FDA.gov