FDA 483 - Sunandana Chandra, M.D., Clinical Investigator - January 27, 2020
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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.
- Inspection Date
- January 27, 2020
- Product Type
- Drugs
- Office
- Chicago District Office
- Person
ID · 7912f596-82ea-4a4d-bc30-989bab8a8c64