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# Ashirwad Hospital Bioresearch Monitoring Issues
- URL: https://www.fdaweb.com/ashirwad-hospital-bioresearch-monitoring-issues/
- Published: 2026-05-12T12:00:00.000Z
- Updated: 2026-09-14T13:39:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161127

A 5/5-5/9/2025 FDA Bioresearch Monitoring Program inspection at Ashirwad Hospital & Research Center in Maharashtra, India, found that the facility and the clinical investigator, **Mukesh Chandre**, failed to obtain informed consent for a clinical *in vivo* bioequivalence study. A 4/29 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mukesh-b-chandre-md-mbbsashirwad-hospital-research-centre-724911-04292026?ref=fdaweb.com) acknowledges the corrective actions the facility and investigator have taken, but says their written response is inadequate because they did not provide sufficient details about how the investigator will ensure adequate compliance with the informed consent regulations in the future.

Chandre was told to respond with a list of specific actions that have been taken to prevent similar violations in the future.