# FDA 483 - Michael L. Levin, M.D. - November 25, 2020

Source: https://www.keypedia.com/records/483/michael-l-levin-md/50a9fb45-e4d3-429a-af99-fe375391ee9e

> FDA 483 for Michael L. Levin, M.D. on November 25, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Michael L. Levin, M.D.
- Inspection Date: 2020-11-25
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Michael L. Levin, M.D. in Las Vegas, NV, a clinical investigator, revealed significant deviations from the investigational plan and inadequate record-keeping. The firm failed to conduct required safety calls and study visits within protocol windows, potentially jeopardizing subject safety. Additionally, issues were noted with staff delegation, laboratory freezer monitoring, review of subject eligibility labs, and the submission of adverse events and concomitant medications to the electronic data capture system.

## Related Officers

- [investigator](https://www.keypedia.com/people/dustin-r-abaonza/0a9994bd-d6ab-47cc-8f1b-5bf4d10bd852)
- [Investigator ](https://www.keypedia.com/people/dustin-tran/52b41643-a5f9-4b2e-8da4-24beca42b1cd)

Company: https://www.keypedia.com/companies/michael-l-levin-md/72582320-ffbd-43ff-a97f-5c176a3a4104

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