483
Samuel J. Maiser, M.D., Clinical InvestigatorFDA 483 - Samuel J. Maiser, M.D., Clinical Investigator - February 11, 2022
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Record Details
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.
- Inspection Date
- February 11, 2022
- Product Type
- Drugs
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ID · 30d96451-fca0-4506-a568-bbdd108e0d9b