Vaccines, Blood & Biologics
HCT/P Inspection Information
Inspections Performed in Fiscal Years 1998 to 2011
Inspection Conclusion by Fiscal Year1
2003 | 2004 | 2005 | 2006 | 2007 | 2008 | 2009 | 2010 | 2011 | |
---|---|---|---|---|---|---|---|---|---|
Inspections Classified NAI * | 160 | 233 | 217 | 249 | 308 | 285 | 309 | 414 | 494 |
Inspections Classified VAI | 53 | 43 | 46 | 96 | 113 | 90 | 112 | 135 | 110 |
Inspections Classified OAI | 5 | 7 | 0 | 10 | 9 | 11 | 14 | 12 | 13 |
Avg. hours per inspection | 33.1 | 33.7 | 32.2 | 44.7 | 46.7 | 37.5 | 41.7 | 41.7 | 39.9 |
*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.
Contact FDA
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