# FDA 483 - Diego A. Rielo, M.D. - June 21, 2024

Source: https://www.globalkeysolutions.net/records/483/diego-a-rielo-md/b7eef981-4afe-409a-b961-0aed012b805d

> FDA 483 for Diego A. Rielo, M.D. on June 21, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Diego A. Rielo, M.D.
- Inspection Date: 2024-06-21
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Premier Clinical Research Institute, Inc. in Miami, FL, was inspected as a clinical investigator and found to have significant deficiencies. The firm failed to conduct an investigation in accordance with the investigational plan, including enrolling a subject who did not meet inclusion criteria and not capturing source data in real-time. Additionally, the firm did not maintain adequate and accurate case histories, with numerous reports containing obliterated and unattributable information.

## Related Documents

- [EIR - 2024-06-15](https://www.globalkeysolutions.net/records/eir/diego-a-rielo-md/abe52629-19c1-48a2-a9c4-1b35a5d93248)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/emily-c-caldwell/101868aa-0586-4d37-8bc6-194f43d66cb7)

Company: https://www.globalkeysolutions.net/companies/diego-a-rielo-md/278b39ef-9820-4045-a841-aabb2b3f3267

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