# FDA 483 - Samuel J. Maiser, M.D., Clinical Investigator - February 11, 2022

Source: https://www.keypedia.com/records/483/samuel-j-maiser-md-clinical-investigator/30d96451-fca0-4506-a568-bbdd108e0d9b

> FDA 483 for Samuel J. Maiser, M.D., Clinical Investigator on February 11, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Samuel J. Maiser, M.D., Clinical Investigator
- Inspection Date: 2022-02-11
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Hennepin Healthcare in Minneapolis, a clinical investigator, revealed a failure to promptly report adverse effects related to an investigational drug. Specifically, the firm did not report a serious adverse event (SAE) and two non-serious adverse events (AEs) within the required timeframe, indicating issues with their adverse event reporting procedures.

## Related Officers

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

Company: https://www.keypedia.com/companies/samuel-j-maiser-md-clinical-investigator/9ec0bb41-52c4-4354-bf6e-eaf723657314

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