# FDA 483 - James A. Simon, MD - May 05, 2023

Source: https://www.keypedia.com/records/483/james-a-simon-md/78f01268-b9d9-4369-9e5d-7d8ac22e8959

> FDA 483 for James A. Simon, MD on May 05, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: James A. Simon, MD
- Inspection Date: 2023-05-05
- Product Type: other
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of James A. Simon, MD, a clinical investigator in Washington, DC, revealed significant deficiencies in the conduct of a clinical investigation and control of investigational devices. The firm failed to ensure subjects met inclusion/exclusion criteria prior to randomization and did not properly account for investigational products. These findings indicate a lack of adherence to study protocols and regulatory requirements for clinical trials.

## Related Officers

- [Consumer Safety Officer/BIMO Investigator](https://www.keypedia.com/people/david-l-chon/227b9c21-14c4-442b-bdc3-ad167567fd92)
- [Lucilla Facchin](https://www.keypedia.com/people/lucilla-facchin/e5c5c863-b2f4-44a8-8093-d1cb4f71949b)

Company: https://www.keypedia.com/companies/james-a-simon-md/18e65559-4dc9-460e-b1d5-0204f1ed4615

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64