# FDA 483 - Francine M. Foss - February 03, 2023

Source: https://www.globalkeysolutions.net/records/483/francine-m-foss/b9ef0754-072d-4607-a1cc-86f9475e7c7d

> FDA 483 for Francine M. Foss on February 03, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Francine M. Foss
- Inspection Date: 2023-02-03
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Francine M. Foss, a clinical investigator in New Haven, CT, was inspected from January 30 to February 3, 2023. The inspection revealed a significant failure to maintain accurate case histories and data pertinent to a clinical investigation. This included incorrect disease staging and tumor burden calculations for multiple subjects in the Electronic Data Capture system.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/kent-a-conforti/8d3d3e82-cd97-420e-8840-df92d6eeba09)

Company: https://www.globalkeysolutions.net/companies/francine-m-foss/a1c57e27-1e18-4a4a-a14a-2d1cce136654

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7