Warning Letter — Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre
The FDA issued a warning letter to Mukesh B. Chandre, M.D., and Ashirwad Hospital & Research Centre following an inspection by the Center for Drug Evaluation and Research (CDER).
Clinical investigators, trial site management organizations, and sponsors monitoring clinical research at Ashirwad Hospital & Research Centre.
Engagement with the Center for Drug Evaluation and Research (CDER) via a Warning Letter typically indicates significant deviations from Good Clinical Practice (GCP) or failure to comply with investigator responsibilities. This may impact the integrity of data submitted to the FDA for drug applications and could lead to disqualification of the investigator or rejection of trial data if issues are not remediated.
Clinical trial sites should conduct immediate internal audits of investigator responsibilities and documentation practices. Quality teams must verify that all site-level activities are conducted in strict accordance with the approved protocol and current GCP standards.
FDA Warning Letter issued to: Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre. 04/29/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mukesh-b-chandre-md-mbbsashirwad-hospital-research-centre-724911-04292026
Open in openFDA / FDA.gov