# FDA 483 - Rishi Kakar, M.D. - August 09, 2021

Source: https://www.keypedia.com/records/483/rishi-kakar-md/3fe1b111-809b-4f73-9dba-32fe424ca82b

> FDA 483 for Rishi Kakar, M.D. on August 09, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rishi Kakar, M.D.
- Inspection Date: 2021-08-09
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Rishi Kakar, M.D., a clinical investigator in Miami Lakes, FL, revealed significant protocol deviations. The firm failed to conduct an investigation in accordance with the signed statement of investigator and investigational plan. Specifically, multiple subjects enrolled in a double-blind study did not have all required baseline evaluations completed as mandated by the study protocol.

## Related Officers

- [investigator](https://www.keypedia.com/people/emily-a-green/99d6d052-ed5c-4d09-9fad-f0d2b740725f)

Company: https://www.keypedia.com/companies/rishi-kakar-md/d040b86d-d6aa-43a7-941e-d74bdb757a3a

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6