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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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HCT/P Inspection Information

Inspections Performed in Fiscal Years 1998 to 2011

Bar Graph of inspections performed in fiscal years 1998 to 2011

 


Inspection Conclusion by Fiscal Year1

 

 2003200420052006
2007
2008
2009
   2010 2011

Inspections Classified NAI *

160233217249
308
285
309

         414

494

Inspections Classified VAI

53434696
113
90
112
135110

Inspections Classified OAI

57010
9
11
14
1213
          

Avg. hours per inspection

33.133.732.244.7
46.7
37.5
41.7
41.739.9

*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, Establishment Inspection Report (EIR) - Inspection Conclusions and District Decisions, June 7, 2007" in the Related Information box on this page.)


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

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Related Information

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Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448
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