# FDA 483 - Filipa Lynce, M.D. - October 21, 2025

Source: https://www.keypedia.com/records/483/filipa-lynce-md/e91439e4-7333-4c29-990f-de65847138bc

> FDA 483 for Filipa Lynce, M.D. on October 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Filipa Lynce, M.D.
- Inspection Date: 2025-10-21
- Product Type: drugs
- Office Name: New England District Office
- Summary: Filipa Lynce, M.D., a sponsor-investigator in Boston, MA, was cited for failing to conduct a clinical investigation in accordance with the general investigational plan and protocols specified in the IND. Specifically, the study team enrolled a fourth subject at an incorrect dose level without protocol requirement and failed to adjust subject enrollment based on adverse events like elevated liver enzymes. These issues indicate significant deviations from proper clinical trial conduct.

## Related Officers

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

Company: https://www.keypedia.com/companies/filipa-lynce-md/fb6effa3-ce85-4fc4-aa1d-9821f8704564

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144