Wednesday, May 7, 2014

FDA: Foreign medtech firms receive excess manufacturing violations | MassDevice

FDA: Foreign medtech firms receive excess manufacturing violations | MassDevice:

"FDA inspectors have stepped up their surveillance of foreign medical device manufacturers, finding that they make up a disproportionate number of process and quality violations that result in formal warning letters.

Foreign firms accounted for about 10% of inspections conducted in 2012 but received 40% of the FDA warning letters. China alone was responsible for 12% of all the quality systems warning letters issued that year."

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