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

Source: https://www.keypedia.com/records/483/filipa-lynce-md/e1571152-fb00-4118-a26b-d08025833e97

> 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: An FDA inspection conducted from October 15-21, 2025, at the Boston, MA facility of Sponsor-Investigator Filipa Lynce, M.D., identified a significant observation regarding a clinical study. The primary issue was the failure to ensure that an investigation was conducted in accordance with the general investigational plan and approved protocols. Specifically, during Cycle II of the Phase portion of a clinical study, the study team improperly enrolled a fourth subject at a particular dose level, a deviation not authorized by the protocol. Furthermore, the document noted that subjects experienced adverse events, such as elevated liver enzymes, which should have triggered specific protocol-mandated actions regarding subsequent subject enrollment or dose adjustments, but these actions were not followed. This observation highlights a breakdown in adherence to the established clinical trial protocol, which is critical for patient safety and data integrity. While the FDA 483 document itself does not specify required actions, it serves as notification of objectionable conditions under Section 704(b) of the Federal Food, Drug and Cosmetic Act, necessitating a prompt response from Dr. Lynce to implement corrective and preventive actions to ensure future compliance with FDA regulations.

## 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/8bfcb49f-49c9-456a-8449-5bbec827b8e6

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