# FDA 483 - Paul Sorajja, M.D., Clinical Investigator - March 22, 2019

Source: https://www.globalkeysolutions.net/records/483/paul-sorajja-md-clinical-investigator/2e0a3a03-63fd-4396-b833-b33156fa67e1

> FDA 483 for Paul Sorajja, M.D., Clinical Investigator on March 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Paul Sorajja, M.D., Clinical Investigator
- Inspection Date: 2019-03-22
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Dr. Paul Sorajja, a clinical investigator in Minneapolis, MN, was cited for two observations during an FDA inspection. The inspection revealed failures in providing subjects with copies of their informed consent forms and significant deviations from the investigational plan. These deviations included unreported adverse events and inadequate staff training for critical study assessments.

## Related Documents

- [483 - 2023-08-25](https://www.globalkeysolutions.net/records/483/paul-sorajja-md-clinical-investigator/8bbf414b-2fb0-4d81-a56a-aa72dfcfe6bf)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/kellie-l-thommes/255a1b92-cd56-41f5-9622-82e8a629e153)

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