# Harinath Sheela, MD – FDA 483, Jul 2, 2026

Source: https://www.keypedia.com/records/483/harinath-sheela-md/88e60bca-13af-425f-b8d2-15959b662751

> FDA 483 for Harinath Sheela, MD on July 02, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Harinath Sheela, MD
- Inspection Date: 2026-07-02
- Product Type: drugs
- Office Name: Florida District Office
- Summary: An FDA inspection of Harinath Sheela, MD in Orlando, FL, revealed significant deficiencies in maintaining adequate and accurate case histories for clinical trials. The firm failed to ensure subject eligibility through consistent documentation, lacked proper record-keeping for procedures, and exhibited multiple data discrepancies and non-contemporaneous data entry. These issues raise serious concerns about the integrity and reliability of the clinical trial data.

## Related Officers

- [Ricardo Vela](https://www.keypedia.com/people/ricardo-vela/b090df1e-9d71-423a-9ec8-efaaaff5dda3)

Company: https://www.keypedia.com/companies/harinath-sheela-md/89dea402-a673-4197-a0ab-a6731230e608

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