483
Sonia K. Kalirao, M.D.FDA 483 - Sonia K. Kalirao, M.D. - January 29, 2026
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The FDA inspected Healthcare Innovations Institute, Llc. in Coral Springs, FL, a clinical investigator. The inspection revealed significant issues with data integrity and record-keeping during a clinical study. Specifically, the firm failed to maintain accurate case histories, including discrepancies in endpoint data transcription, duplicate diaries, and undocumented adverse event reporting.
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ID · 37fcf2b4-bc50-472e-8ddc-6a2e5388332f