# FDA 483 - Michele Nanna, M.D. - March 25, 2021

Source: https://www.keypedia.com/records/483/michele-nanna-md/041481fb-a4ed-4004-aa9d-80c16307acfb

> FDA 483 for Michele Nanna, M.D. on March 25, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Michele Nanna, M.D.
- Inspection Date: 2021-03-25
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: This FDA Form 483 was issued to Michele Nanna, M.D., a clinical investigator in Bronx, NY, following an inspection from March 22-25, 2021. The inspection revealed two significant observations related to the conduct of clinical investigations. Issues included a failure to adhere to the investigational plan and protocol inclusion criteria for a subject, as well as inadequate investigational drug disposition records with inconsistencies in tracking and documentation.

## Related Officers

- [investigator](https://www.keypedia.com/people/benton-m-ketron/34d763d8-4374-4c8b-8dd6-dce1a83dcd01)

Company: https://www.keypedia.com/companies/michele-nanna-md/4885666b-5caf-4ea0-b280-6391bae66ba2

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961
