# FDA 483 - Sunandana Chandra, M.D., Clinical Investigator - January 27, 2026

Source: https://www.globalkeysolutions.net/records/483/sunandana-chandra-md-clinical-investigator/7912f596-82ea-4a4d-bc30-989bab8a8c64

> FDA 483 for Sunandana Chandra, M.D., Clinical Investigator on January 27, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sunandana Chandra, M.D., Clinical Investigator
- Inspection Date: 2026-01-27
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Sunandana Chandra, M.D., Clinical Investigator, in Chicago, revealed significant non-compliance with clinical trial protocols and regulatory requirements. The firm failed to adhere to the investigational plan, including issues with dose modifications, timely adverse event reporting, and proper drug accountability. Additionally, deficiencies were noted in the informed consent process, specifically regarding the witnessing of short-form consent documents.

## Related Officers

- [Debra L. Boyd-Seale](https://www.globalkeysolutions.net/people/debra-l-boyd-seale/6f9af6f9-8deb-494d-b73e-fca63b95d7d2)

Company: https://www.globalkeysolutions.net/companies/sunandana-chandra-md-clinical-investigator/7ac2e8ce-2bb8-4717-bc57-935e1bc9d8e4

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