Main The number of high-risk product inspections where objectionable conditions were found and a regulatory action is recommended are classified as an Official Action Indicated. This includes voluntary recalls initiated by the firm, or FDA requested recalls when the firm is hesitant to conduct a voluntary recall. Number Classified as OAI column 0 100 0 75

FY 2010 Overall: 500

Oct 2009 29 Nov 2009 46 Dec 2009 28 Jan 2010 36 Feb 2010 37 Mar 2010 39 Apr 2010 36 May 2010 44 Jun 2010 55 Jul 2010 42 Aug 2010 44 Sep 2010 64 0 75

FY 2011 Overall: 676

Oct 2010 40 Nov 2010 64 Dec 2010 49 Jan 2011 49 Feb 2011 47 Mar 2011 60 Apr 2011 65 May 2011 73 Jun 2011 59 Jul 2011 46 Aug 2011 70 Sep 2011 54

FY 2012 Total: 579

Oct 2011 31 Nov 2011 40 Dec 2011 42 Jan 2012 35 Feb 2012 41 Mar 2012 48 Apr 2012 32 May 2012 51 Jun 2012 69 Jul 2012 57 Aug 2012 71 Sep 2012 62 Sub Number of highest risk domestic inspections in the month resulting in a classification of Official Action Indicated (OAI) Percent Classified as OAI 0 100 0 100

Oct 2009 4 Nov 2009 5 Dec 2009 3 Jan 2010 4 Feb 2010 4 Mar 2010 3 Apr 2010 4 May 2010 5 Jun 2010 4 Jul 2010 5 Aug 2010 5 Sep 2010 7 0 100

Oct 2010 4 Nov 2010 6 Dec 2010 4 Jan 2011 5 Feb 2011 5 Mar 2011 4 Apr 2011 7 May 2011 7 Jun 2011 5 Jul 2011 6 Aug 2011 7 Sep 2011 7

Oct 2011 3 Nov 2011 3 Dec 2011 3 Jan 2012 3 Feb 2012 3 Mar 2012 3 Apr 2012 3 May 2012 4 Jun 2012 6 Jul 2012 6 Aug 2012 7 Sep 2012 7 http://www.fda.gov/AboutFDA/Transparency/track/ucm204013.htm FDA-TRACK ORA Regional Offices Dashboard ਍††਍਍਍਍਍਍਍