# FDA 483 - Shuo Ma, M.D. - May 06, 2022

Source: https://www.globalkeysolutions.net/records/483/shuo-ma-md/464655d8-9981-47c5-ae4b-64f094e8a429

> FDA 483 for Shuo Ma, M.D. on May 06, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shuo Ma, M.D.
- Inspection Date: 2022-05-06
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Shuo Ma, M.D. in Chicago, IL, revealed significant non-compliance with an investigational plan for Protocol EA9161. Key issues included a subject receiving investigational product for an extended period beyond protocol guidelines and the failure to report eleven serious adverse events within required timeframes. Additionally, a subject was administered a drug that should have been withheld during a neutropenia event, contrary to protocol.

## Related Officers

- [Rachel E Mcguigan](https://www.globalkeysolutions.net/people/rachel-e-mcguigan/da725842-7858-402e-a99c-71a4b95dd8e1)
- [investigator](https://www.globalkeysolutions.net/people/colleen-e-burke/e013131b-6c14-4a60-b3ab-d8759d38624b)
- [investigator](https://www.globalkeysolutions.net/people/jeanne-j-thai/f7b057a4-ab4c-43de-a448-384ff9f8598f)

Company: https://www.globalkeysolutions.net/companies/shuo-ma-md/b03e448b-7933-429e-bc0a-3a8cfb396597

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669