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Ultrasound Company Warned on Documentation, Validation

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A bevy of documentation shortcomings led to a warning letter for Compumedics Germany. The company makes Doppler ultrasonic imaging diagnostic systems. The Aug. 1 warning letter listing nine deviations was posted to the FDA’s website Aug. 13 and followed a March 19-22 inspection of the company’s Singen, Germany, plant.
Devices & Diagnostics Letter