# FDA 483 - John C. Lieske, M.D., Clinical Investigator - March 03, 2023

Source: https://www.globalkeysolutions.net/records/483/john-c-lieske-md-clinical-investigator/7f5ffbe9-e1dc-4da0-9ff5-4d0979ebbb87

> FDA 483 for John C. Lieske, M.D., Clinical Investigator on March 03, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: John C. Lieske, M.D., Clinical Investigator
- Inspection Date: 2023-03-03
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of John C. Lieske, M.D., Clinical Investigator in Rochester, MN, revealed significant deficiencies in adverse event reporting. The firm failed to report serious adverse events, including those involving hospitalization, to the study sponsor as required by protocol. Additionally, non-serious adverse events were not reported to the sponsor in accordance with the study protocol's specified timetable.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/john-c-lieske-md-clinical-investigator/e685fd45-bb44-46af-b8a1-9cc21deb7042

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