Home » Ultrasound Company Warned on Documentation, Validation
Ultrasound Company Warned on Documentation, Validation
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
Devices & Diagnostics Letter
Upcoming Events
-
28Mar
-
04Apr
-
11Apr
-
14Apr
-
25Apr
-
14May