# FDA 483 - Nicolas J. Mouawad, MD - March 20, 2026

Source: https://www.keypedia.com/records/483/nicolas-j-mouawad-md/a6329b26-33cc-449a-be0d-b98e3335a227

> FDA 483 for Nicolas J. Mouawad, MD on March 20, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nicolas J. Mouawad, MD
- Inspection Date: 2026-03-20
- Product Type: device
- Office Name: Detroit District Office
- Summary: Nicolas J. Mouawad, MD, a clinical investigator in Bay City, MI, was cited for significant deficiencies in record-keeping during a device study inspection. Observations included inaccurate and incomplete device accountability records with conflicting lot numbers, insufficient documentation for the return or disposition of deficient devices, and a failure to properly identify subjects on source documentation related to device exposure. These issues indicate a lack of robust data integrity and accountability in the clinical investigation.

## Related Officers

- [investigator](https://www.keypedia.com/people/dina-a-tallman/e9bf2b98-6697-4d7c-9052-84339536acfd)

Company: https://www.keypedia.com/companies/nicolas-j-mouawad-md/5856acc1-92bc-465f-a859-53d8398f58ba

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03