# FDA 483 - Michael J Rosen MD - March 01, 2023

Source: https://www.globalkeysolutions.net/records/483/michael-j-rosen-md/17b4f4cd-6699-4fa2-97b6-67e35d3f2901

> FDA 483 for Michael J Rosen MD on March 01, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Michael J Rosen MD
- Inspection Date: 2023-03-01
- Product Type: other
- Office Name: Cincinnati District Office
- Summary: The FDA inspected Cleveland Clinic Found, a principal investigator site in Cleveland, OH, from February 14 to March 1, 2023. The inspection revealed that serious adverse events (SAEs) were not reported to the sponsor within the protocol-required 24-hour timeframe for multiple subjects. This indicates a failure to conduct the investigation in accordance with the signed agreement and investigational plan.

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Company: https://www.globalkeysolutions.net/companies/michael-j-rosen-md/5622747c-bbd1-4223-988f-e53dfc70e17c

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22