# FDA 483 - Alexandra Rogers, MD - October 01, 2021

Source: https://www.globalkeysolutions.net/records/483/alexandra-rogers-md/6d0d7976-58b4-4000-b7fd-e1e5467dd8e0

> FDA 483 for Alexandra Rogers, MD on October 01, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alexandra Rogers, MD
- Inspection Date: 2021-10-01
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Dr. Alexandra Rogers, MD in Santa Barbara, CA, a clinical investigator, was cited for failing to conduct an investigation in accordance with the signed agreement, investigational plan, and applicable FDA regulations. Specifically, the firm did not report all adverse events relating to an enrolled subject's conditions and treatments. Additionally, Dr. Rogers failed to timely disclose a financial interest in the sponsoring company to the IRB.

## Related Officers

- [Bioresearch Monitoring Specialis](https://www.globalkeysolutions.net/people/denise-l-burosh/075a442f-67e0-4a65-9c09-e8819a329773)

Company: https://www.globalkeysolutions.net/companies/alexandra-rogers-md/9717c055-73bb-4312-8047-792f12be6536

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6