An FDA report of medical device inspections shows that foreign firms make up a 40% of manufacturing violations that result in warning letters, even though they only make up 10% of inspections.
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.
from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1kHXgOS
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