Jul 15, 2011

The growing rate of US Food and Drug Administration inspections and warning letter issuances, already higher than last year, will continue to increase according to a report by FDANews.com (subscription required).

The agency distributed 673 warning letters in 2010 according to an unnamed FDA official cited by FDANews. So far this year, 874 warning letters have been issued by the FDA—with five months left in 2011, that number will no doubt increase further.

Given the FDA’s broader approach in terms of regulatory enforcement in recent months, stepping up inspections and warning letter issuance should come as no surprise. Medical device manufacturers should best prepare accordingly.


  • Stewart Eisenhart