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  1. Compliance Actions (Biologics)

HCT/P Inspection Information

Inspections Performed in Fiscal Years 2014 to 2018

This graph provides the number of inspections performed in fiscal year 2013 to 2017. The number of inspections is listed in the table below.



Inspection Conclusion by Fiscal Year1

Inspection Conclusion by Fiscal Year
  2014 2015 2016 2017 2018
Inspections Classified NAI 524 501 541 561 529
Inspections Classified VAI 130 97 97 57 93
Inspections Classified OAI 8 8 5 8 12
Number of Inspections 652 598 636 621 625
Avg. hours per Inspection 35.4 34.4 38.1 36.9 37.8

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