# FDA 483 - Mark Roschewski, M.D. - April 15, 2024

Source: https://www.globalkeysolutions.net/records/483/mark-roschewski-md/3a4a08e1-c5d7-4f04-9679-003c7d47f83a

> FDA 483 for Mark Roschewski, M.D. on April 15, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mark Roschewski, M.D.
- Inspection Date: 2024-04-15
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: Mark Roschewski, M.D. in Bethesda, MD, a clinical investigator, was inspected by the FDA from April 8-15, 2024. The inspection revealed that an investigation was not conducted in accordance with the signed statement of investigator and investigational plan. Specifically, subjects who screened positive for a core antibody did not receive required follow-up testing as outlined in the protocol.

## Related Documents

- [483 - 2021-05-11](https://www.globalkeysolutions.net/records/483/mark-roschewski-md/43f19a7d-e9e3-40a3-bc78-e6f33e58e89c)

## Related Officers

- [Consumer Safety Officer/BIMO Investigator](https://www.globalkeysolutions.net/people/david-l-chon/227b9c21-14c4-442b-bdc3-ad167567fd92)
- [Lee Hong Pai Scherf](https://www.globalkeysolutions.net/people/lee-hong-pai-scherf/e6cb2433-ec2b-463f-8beb-5f2bc90a9291)

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

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64