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

Source: https://www.keypedia.com/records/483/sonia-k-kalirao-md/37fcf2b4-bc50-472e-8ddc-6a2e5388332f

> FDA 483 for Sonia K. Kalirao, M.D. on January 29, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sonia K. Kalirao, M.D.
- Inspection Date: 2026-01-29
- Product Type: drugs
- Office Name: Florida District Office
- Summary: 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.

## Related Officers

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Company: https://www.keypedia.com/companies/sonia-k-kalirao-md/bf779822-d207-49bf-a6ba-fb754d222f57

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9
