Warning Letters Last Year Dropped by 15%

FDA Warning Letters issued in fiscal year (FY) 2016 fell by 15% compared with such letters issued in FY 2015, according to just-released enforcement statistics. Overall, there were 14,590 Warning Lettters issued in FY 2016, down about 2,600 from the 17,232 letters issued in 2015. The majority of Warning Letters, and the majority of the drop in letters, was seen in the Center for Tobacco Products (CTP), which sends thousands of letters to retailers for violations in tobacco product sales. For example, 14,032 CTP-related letters were issued in FY 2016, which is 2,597 fewer letters from the Center than the 16,629 issued in FY 2015.

For medical product Centers, CDRH saw almost a 50% drop in Warning Letters last year (168 letters in 2015 vs 85 letters in 2016). Meanwhile, CDER letters doubled from 76 issued in 2015 to 151 in 2016, with the majority of this increase likely attributed to the increase in foreign inspections. CBER letters remained unchanged at four each for the past two years.