Enforcement Statistics, Fiscal 2012, published by FDA

The U.S. Food and Drug Administration compiled and published these data about its enforcement activities during fiscal 2012 (October 1, 2011 to September 30, 2012).

In past years they had also published totals for the number of inspections conducted and the numbers of Form 483s issued.  The dramatic uptick in Warning Letters is attributable largely to FDA’s tobacco-related activities.

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