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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 2004 to 2013

 Inspections Performed in Fiscal Years 2004 to   2013

 

Inspection Conclusion by Fiscal Year

 

2004

2005

2006

2007

2008

2009

2010

2011

2012

2013

Inspections Classified NAI *

233

217

249

308

285

309

414

494

 

432

 

520

Inspections Classified VAI

43

46

96

113

90

112

135

110

 

151

 

145

Inspections Classified OAI

7

0

10

9

11

14

12

13

 

15

 

13

 

 

 

 

 

 

 

 

 

 

 

Avg. hours per Inspection

33.7

32.2

44.7

46.7

37.5

41.7

41.7

39.9

 

39.4

 

40.1

*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.)


[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
(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