Vaccines, Blood & Biologics

HCT/P Inspection Information

Inspections Performed in Fiscal Years 2005 to 2014

 
Inspections Performed in Fiscal Years 2005 to 2014, see table below for numbers
 

Inspection Conclusion by Fiscal Year1

Inspection Conclusion by Fiscal Year
  2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
Inspections Classified NAI* 217 249 308 285 309 414 494 432 520 524
Inspections Classified VAI 46 96 113 90 112 135 110 151

 

145 130
Inspections Classified OAI 0 10 9 11 14 12 13 15

 

13 8
Avg. hours per Inspection 32.2 44.7 46.7 37.5 41.7 41.7 39.9 39.4 40.1 35.4

*NAI = No Action Indicated, meaning no objectionable conditions or practices were found during the inspection (or the significance of the documented objectionable conditions found does not justify further action).

VAI = Voluntary Action Indicated, meaning objectionable conditions were found and documented but the agency is not prepared to take or recommend regulatory action.

OAI = Official Action Indicated, meaning objectionable conditions were found and regulatory action should be recommended.

(See also the ORA Field Management Directive No. 86 (PDF), Establishment Inspection Report (EIR) - Inspection Conclusions and District Decisions.)


[1]Sum of inspection classifications does not equal total number of inspections performed by fiscal year due to data constraints

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 02/27/2015
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