Main VAI classifications result when FDA provides the firm the opportunity to voluntarily correct the problems noted during the inspection. Number Classified as VAI column 0 100 0 475

FY 2010 Overall: 4,429

Oct 2009 310 Nov 2009 376 Dec 2009 368 Jan 2010 334 Feb 2010 350 Mar 2010 450 Apr 2010 372 May 2010 345 Jun 2010 482 Jul 2010 351 Aug 2010 338 Sep 2010 353 0 475

FY 2011 Overall: 4,837

Oct 2010 406 Nov 2010 484 Dec 2010 451 Jan 2011 333 Feb 2011 388 Mar 2011 559 Apr 2011 379 May 2011 439 Jun 2011 455 Jul 2011 324 Aug 2011 352 Sep 2011 267

FY 2012 Total: 5,166

Oct 2011 339 Nov 2011 450 Dec 2011 449 Jan 2012 453 Feb 2012 458 Mar 2012 567 Apr 2012 423 May 2012 501 Jun 2012 486 Jul 2012 373 Aug 2012 376 Sep 2012 291 Sub Number of highest risk domestic inspections in the month resulting in a classification of Voluntary Action Indicated (VAI) Percent Classified as VAI 0 100

Oct 2009 45 Nov 2009 42 Dec 2009 40 Jan 2010 38 Feb 2010 40 Mar 2010 38 Apr 2010 40 May 2010 36 Jun 2010 35 Jul 2010 41 Aug 2010 36 Sep 2010 39 0 100

Oct 2010 44 Nov 2010 42 Dec 2010 40 Jan 2011 36 Feb 2011 42 Mar 2011 42 Apr 2011 40 May 2011 41 Jun 2011 38 Jul 2011 44 Aug 2011 35 Sep 2011 34

Oct 2011 32 Nov 2011 36 Dec 2011 34 Jan 2012 38 Feb 2012 37 Mar 2012 37 Apr 2012 40 May 2012 43 Jun 2012 41 Jul 2012 41 Aug 2012 35 Sep 2012 35 http://www.fda.gov/AboutFDA/Transparency/track/ucm204013.htm FDA-TRACK ORA Regional Offices Dashboard ਍††਍਍਍਍਍਍਍