FDA 483 - Sonia K. Kalirao, M.D. - January 29, 2026

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.