Maker of Blood Pressure Monitors Gets Warning for Quality Deficiencies

German devicemaker I.E.M. was hit with a warning letter after FDA investigators found shortcomings with medical device report (MDR) procedures and an array of quality “nonconformities” during a recent inspection of the company’s Stolberg, Germany, facility. During a three-day, October 2011 inspection, investigators found that I.E.M. lacks internal systems for providing timely and effective identification, evaluation and communication of events that may trigger MDR requirements, the warning letter states.
The GMP Letter