# FDA 483 - Michael B. Jacobs, M.D. - December 20, 2022

Source: https://www.globalkeysolutions.net/records/483/michael-b-jacobs-md/c999d87b-8031-488c-b40b-c7a5013445d1

> FDA 483 for Michael B. Jacobs, M.D. on December 20, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Michael B. Jacobs, M.D.
- Inspection Date: 2022-12-20
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Michael B. Jacobs, M.D. in Las Vegas, NV, was inspected for Bioresearch Monitoring and received a Form 483 with three observations. The inspection revealed significant issues including protocol deviations, failure to obtain proper informed consent for study procedures, and inadequate maintenance of case histories. These findings indicate a lack of adherence to regulatory requirements for clinical investigations.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/rebecca-t-davis/a821f7ef-0c73-4be1-9a9b-3fc2c07f88c1)

Company: https://www.globalkeysolutions.net/companies/michael-b-jacobs-md/c846130c-4390-4de2-8c29-05064e700e05

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b