# FDA 483 - Robert Litman, M.D. - February 20, 2020

Source: https://www.globalkeysolutions.net/records/483/robert-litman-md/adaff111-b12b-492c-8d27-e9b87cb83366

> FDA 483 for Robert Litman, M.D. on February 20, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Robert Litman, M.D.
- Inspection Date: 2020-02-20
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Robert Litman, M.D. in Gaithersburg, MD, identified a significant deviation from an investigational plan. The clinical investigator failed to consult with the sponsor's medical monitor prior to adjusting a subject's antidepressant treatment dose, as required by the study protocol. This indicates a failure to adhere to established clinical trial procedures for a study involving intranasal esketamine for major depressive disorder.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/young-m-yoon/fe5ad575-57d1-4329-9e4b-a997ed79499c)

Company: https://www.globalkeysolutions.net/companies/robert-litman-md/f4a2d872-0435-4df3-9949-2fda169fc6c3

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e