Vaccines, Blood & Biologics

HCT/P Inspection Information

Inspections Performed in Fiscal Years 2012 to 2016

 Inspections Performed in FIscal Years 2012 to 2016


Inspection Conclusion by Fiscal Year1

Inspection Conclusion by Fiscal Year
Inspections Classified NAI*432520524501541
Inspections Classified VAI1511451309797
Inspections Classified OAI1513885
Avg. hours per Inspection39.440.135.434.438.1

*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 (PDF), 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
(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: 05/31/2017
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