# FDA 483 - Sunandana Chandra, M.D. - June 16, 2021

Source: https://www.keypedia.com/records/483/sunandana-chandra-md/d1e3995e-5956-4035-86d0-8abf917d45ad

> FDA 483 for Sunandana Chandra, M.D. on June 16, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sunandana Chandra, M.D.
- Inspection Date: 2021-06-16
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Jeffrey A. Sosman, M.D., a clinical investigator in Chicago, IL, revealed significant deviations from the investigational plan. The firm failed to conduct the study in accordance with the protocol, specifically regarding subject enrollment, screening procedures, and required laboratory assessments. These failures resulted in subjects receiving investigational product without meeting inclusion criteria or having critical exclusion criteria properly evaluated.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/yuanyuan-li/2043568b-a6ac-4f49-8018-c2c8edda8ac5)
- [investigator](https://www.keypedia.com/people/jeanne-j-thai/f7b057a4-ab4c-43de-a448-384ff9f8598f)

Company: https://www.keypedia.com/companies/sunandana-chandra-md/a091d168-e82f-4647-bf29-22c91ba6fc32

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