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

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.