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

FOUNDATION MEDICINE, INC. in Boston, MA, a manufacturer of cancer biomarker diagnostic tests, was cited for three observations during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, control non-conforming products, and document justifications for not reporting corrections to the FDA. These issues stemmed from a software error in their FoundationOne CDx and Liquid CDx products, which had the potential to result in false negative companion diagnostic tests.