# FDA 483 - Mark Roschewski, M.D. - May 11, 2021

Source: https://www.globalkeysolutions.net/records/483/mark-roschewski-md/43f19a7d-e9e3-40a3-bc78-e6f33e58e89c

> FDA 483 for Mark Roschewski, M.D. on May 11, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mark Roschewski, M.D.
- Inspection Date: 2021-05-11
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Mark Roschewski, M.D., a clinical investigator in Bethesda, MD, was cited for failing to conduct an investigation in accordance with the signed statement of investigator and investigational plan. This involved two protocols where patients at moderate or high risk did not receive required monitoring or treatments, leading to severe adverse events, including a patient's death. The inspection revealed significant deviations from established protocols, raising concerns about patient safety and study integrity.

## Related Documents

- [483 - 2024-04-15](https://www.globalkeysolutions.net/records/483/mark-roschewski-md/3a4a08e1-c5d7-4f04-9679-003c7d47f83a)

## Related Officers

- [Consumer Safety Officer/BIMO Investigator](https://www.globalkeysolutions.net/people/david-l-chon/227b9c21-14c4-442b-bdc3-ad167567fd92)

Company: https://www.globalkeysolutions.net/companies/mark-roschewski-md/ea0723cb-f67f-4b83-a845-0e1c0b6e9f92

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