FDA Says Inspections, Warning Letters to Foreign Medical Device Companies Up in 2012
The number of warning letters issued by the Food and Drug Administration for violations of quality system regulations by medical devices steadily rose between 2009 and 2012, according to data recently released by the agency. That’s partly a result of more inspections, but is also the result of an increased focus on foreign firms, said FDA in the FDA Medical Device 2012 Quality System Data posted to FDA’s website May 2.
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Overall, the number of routine medical device quality system inspections increased by 37 percent, in from 2011 to 2012, with the number of inspections of foreign firms increasing by 93 percent, said FDA. The most common violations observed included failures in corrective and preventative actions and inadequate production and process controls, said the report. The number of violations related to failure to maintain an adequate device history record “increased significantly” in 2012, said the agency.
Likewise, the number of warning letters increased to 164 sent in 2012 from 122 in 2011, 89 and 2010, and 77 in 2009. While foreign firms only accounted for about 10 percent of inspections in 2012, they accounted for 66 of the 164 warning letters issued, or about 40 percent. Companies in the U.S. were issued 98 warning letters in 2012. The foreign countries with the most recipients of warning letters on medical devices were China (20), Germany (9), Italy (6) and the United Kingdom (6). Denmark (3), Japan (3), Taiwan (3) and Canada (2) rounded out the top 10.