# FDA 483 - Joel Schlessinger, M.D. - December 12, 2019

Source: https://www.keypedia.com/records/483/joel-schlessinger-md/14e2e217-e113-41d4-b50f-e27162a6f26f

> FDA 483 for Joel Schlessinger, M.D. on December 12, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Joel Schlessinger, M.D.
- Inspection Date: 2019-12-12
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Joel Schlessinger, M.D., a clinical investigator in Omaha, NE, revealed a significant failure to report adverse effects. The firm did not document adverse events, which were deemed probably related to investigational products, in the electronic data capture system for multiple subjects. This indicates a serious lapse in clinical trial oversight and reporting.

## Related Officers

- [investigator](https://www.keypedia.com/people/vickie-j-kanion/4ec38844-d90f-490e-bdfb-7bcee20fcc90)

Company: https://www.keypedia.com/companies/joel-schlessinger-md/43825d93-b0cc-4998-a844-76df360610ee

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8