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Vaccines, Blood & Biologics

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HCT/P Inspection Information

Inspections Performed in Fiscal Years 1998 to 2008

 

Inspection performed in fiscal years 1998 to 2008. Fiscal year 1998 - 11 inspections. Fiscal year 1999 - 65 inspections. Fiscal year 2000 - 93 inspections. Fiscal year 2001 - 132 inspections. FY 2002


Inspection Conclusion by Fiscal Year1

 

 

2003

2004

2005

2006

2007
2008

Inspections Classified NAI *

160

233

217

249

308
285

Inspections Classified VAI

53

43

46

96

113
90

Inspections Classified OAI

5

7

0

10

9
11
             

Avg. hours per inspection

33.1

33.7

32.2

44.7

46.7
37.5

*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 Us

  • Consumer Affairs Branch (CBER)

  • (800) 835-4709
  • (301) 827-1800
  • 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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