# FDA 483 - Jonathan Tolins, M.D. - November 15, 2024

Source: https://www.globalkeysolutions.net/records/483/jonathan-tolins-md/6a6888f4-0a30-456f-aaf3-742cd218a397

> FDA 483 for Jonathan Tolins, M.D. on November 15, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jonathan Tolins, M.D.
- Inspection Date: 2024-11-15
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Davita Clinical Research in Minneapolis, MN, identified a significant issue regarding the oversight of a clinical investigation. The clinical investigator failed to ensure that investigational product was administered by protocol-trained dialysis nurses, leading to critical deviations. These deviations included missing required treatments and incorrect dosing of the investigational product for study subjects.

## Related Officers

- [Assistant Country Director, Regulatory Specialist BIMO](https://www.globalkeysolutions.net/people/alanna-l-mussawwir-bias/1283ff1a-34dd-4d90-9389-7bff2570527d)

Company: https://www.globalkeysolutions.net/companies/jonathan-tolins-md/1e4169a1-377b-4167-80ab-aab513e3fe60

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