# FDA 483 - Manish Jain, M.D. - January 24, 2022

Source: https://www.globalkeysolutions.net/records/483/manish-jain-md/89870c40-fc7e-4bd6-ae00-c42ba3d210b3

> FDA 483 for Manish Jain, M.D. on January 24, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Manish Jain, M.D.
- Inspection Date: 2022-01-24
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Manish Jain, M.D. revealed significant deficiencies in the conduct of a clinical investigation for a COVID-19 study. The firm failed to adhere to the investigational plan, resulting in incorrect investigational product dosing and improper informed consent procedures. Additionally, issues were noted with inadequate investigational drug disposition records and a failure to maintain accurate and complete case histories.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/yuanyuan-li/2043568b-a6ac-4f49-8018-c2c8edda8ac5)
- [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/manish-jain-md/da375380-1415-42d2-930c-4be632e6c40f

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