483
Aarti K. Bhatia, MD, MPHAarti K. Bhatia, MD, MPH – FDA 483, Aug 7, 2026
Record Details
An FDA inspection of Aarti K. Bhatia, MD, MPH, a clinical investigator in New Haven, CT, revealed a significant deficiency related to informed consent. The firm failed to obtain legally effective informed consent or reconsent from multiple subjects for updated ICF versions as required by the IRB. This indicates a serious lapse in protecting human subjects in clinical trials.
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ID · 801078b2-8fa6-426c-a359-b9ac0421e523
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