# FDA 483 - Chandan B. Mehta, MD - November 21, 2019

Source: https://www.keypedia.com/records/483/chandan-b-mehta-md/cfadfb5e-26c4-4351-8d40-4d099b45e835

> FDA 483 for Chandan B. Mehta, MD on November 21, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chandan B. Mehta, MD
- Inspection Date: 2019-11-21
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Chandan B. Mehta, M.D., Clinical Investigator in Detroit, MI, revealed significant deviations from the investigational plan and proper device control. Observations included failure to follow disease-specific inclusion criteria, lack of Institutional Review Board submission for protocol updates, and unauthorized use of an investigational device on a randomized subject. These issues indicate a lack of adherence to regulatory requirements for clinical investigations.

## Related Officers

- [Andrace Deyampert](https://www.keypedia.com/people/andrace-deyampert/cdb4f833-488b-42b9-abab-4216435bce4c)

Company: https://www.keypedia.com/companies/chandan-b-mehta-md/f8c870d2-a7b2-448f-86ef-b166268e3b07

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0