# FDA 483 - Paul Sorajja, M.D., Clinical Investigator - August 25, 2023

Source: https://www.globalkeysolutions.net/records/483/paul-sorajja-md-clinical-investigator/8bbf414b-2fb0-4d81-a56a-aa72dfcfe6bf

> FDA 483 for Paul Sorajja, M.D., Clinical Investigator on August 25, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Paul Sorajja, M.D., Clinical Investigator
- Inspection Date: 2023-08-25
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Paul Sorajja, M.D., Clinical Investigator in Minneapolis, MN, revealed a significant issue regarding the conduct of a clinical investigation. The firm failed to capture and timely report all serious adverse events (SAEs) in accordance with the signed agreement, investigational plan, applicable FDA regulations, and IRB conditions. This indicates a serious lapse in patient safety and regulatory compliance during the clinical trial.

## Related Documents

- [483 - 2019-03-22](https://www.globalkeysolutions.net/records/483/paul-sorajja-md-clinical-investigator/2e0a3a03-63fd-4396-b833-b33156fa67e1)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/sharon-l-matson/1d2e6d91-1d00-455d-a2e6-a73b1c6b82cc)

Company: https://www.globalkeysolutions.net/companies/paul-sorajja-md-clinical-investigator/3122779d-6e12-46e7-a5b3-609479cb3205

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d