# FDA 483 - Suken A. Shah, MD - June 01, 2023

Source: https://www.keypedia.com/records/483/suken-a-shah-md/54875738-deae-4c70-a1fd-19dae7336560

> FDA 483 for Suken A. Shah, MD on June 01, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Suken A. Shah, MD
- Inspection Date: 2023-06-01
- Product Type: other
- Office Name: Philadelphia District Office
- Summary: Suken A. Shah, MD, a Sponsor-Investigator in Wilmington, DE, was cited for significant deficiencies during an FDA inspection of an investigational study. Observations included a lack of proper monitoring documentation and inadequate staff training. The firm also failed to adhere to the investigational plan regarding adverse event reporting and submission of Data Safety Monitoring Board reports to the IRB.

## Related Officers

- [Joseph L. Despins](https://www.keypedia.com/people/joseph-l-despins/c84402a8-7ebb-45ab-b1b9-c43a143c5fb8)

Company: https://www.keypedia.com/companies/suken-a-shah-md/e93f9648-3a89-4777-b738-c17607da778d

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8