Officials from the Food and Drug Administration conducted 1,423 quality system inspections at medical device manufacturers in 2008, compared with 2,121 in 2011 and 2,087 in 2012.
Quality system inspections resulting in citations have also significantly increased since the FDA began inspecting device companies more aggressively. The number of warning letters has climbed steadily, from 77 in 2009 to 164 in 2012.
The study said medical device manufacturers should expect the trend of stepped-up FDA inspections to continue through the Obama administration’s second term. Based on data, FDA regulators seem to have heightened interest in manufacturers’ corrective and preventative actions and production and process controls.
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