# FDA 483 - Orlando L. Rivero, MD - June 08, 2023

Source: https://www.keypedia.com/records/483/orlando-l-rivero-md/de077aa5-f36c-447a-a85a-66b7ffa53adc

> FDA 483 for Orlando L. Rivero, MD on June 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Orlando L. Rivero, MD
- Inspection Date: 2023-06-08
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Orlando L. Rivero, MD, a clinical investigator in Miami, revealed two significant observations related to the conduct of a clinical study. The firm failed to obtain proper informed consent for one subject and did not conduct the investigation in accordance with the investigational plan, specifically regarding access to unblinded records. These issues indicate deficiencies in human subject protection and adherence to study protocols.

## Related Officers

- [investigator](https://www.keypedia.com/people/emily-a-baldwin/92d70174-7029-44f4-af30-e3230d4e9507)

Company: https://www.keypedia.com/companies/orlando-l-rivero-md/c1614465-b636-457e-9ef7-8c67b1579692

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