FOUNDATION MEDICINE, INC. – FDA 483, Jan 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.
ID · c1295a87-19ca-4c69-b411-86a70e071a6d
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