# FDA 483 - FOUNDATION MEDICINE, INC. - January 28, 2025

Source: https://www.keypedia.com/records/483/foundation-medicine-inc/b9062208-483a-4763-a33f-933180e7d582

> FDA 483 for FOUNDATION MEDICINE, INC. on January 28, 2025. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FOUNDATION MEDICINE, INC.
- Inspection Date: 2025-01-28
- Product Type: devices
- Office Name: New England District Office
- Summary: The FDA conducted an inspection of a medical device firm, a manufacturer of diagnostic devices such as FoundationOne CDx and FoundationOne Liquid CDx, from January 7 to January 28, 2025. This Form FDA-483 identifies several critical observations related to the firm's quality system procedures, indicating non-compliance with regulatory requirements.

The inspection revealed three primary deficiencies. Firstly, the firm's procedures for corrective and preventive actions (CAPA) were found to be inadequate. A significant software error, capable of producing false negative results in cancer diagnostic tests and potentially impacting patient therapeutic decisions, was not escalated to a CAPA, with the firm citing its risk assessment threshold as justification. Secondly, controls over non-conforming products were insufficient. Specifically, detailed documentation was lacking for a database query performed to identify clinical samples affected by a biomarker configuration error, including its scope, inventory of affected samples, or communication to physicians. Lastly, the firm failed to provide a documented justification for not reporting a correction or removal action related to the software error to the FDA, and a mandatory Post Market Risk Assessment was absent. The firm has committed to correcting these observations.

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/foundation-medicine-inc/33091073-cc93-4bd3-a3a0-e5ebe273b0dc

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