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Criticare Technologies, Inc. was cited for manufacturing patient monitors, including the nGenuity patient vital signs monitor, in violation of FDA's Quality System regulation (21 CFR Part 820). The FDA's March-May 2024 inspection identified that the company failed to establish and maintain adequate procedures for corrective and preventive actions (CAPA), specifically lacking sufficient detail to identify causes of nonconforming product, conduct investigations, and verify corrective measures. The devices were determined to be adulterated due to manufacturing methods and controls that did not conform to current good manufacturing practices.