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  1. Compliance Actions (Biologics)

HCT/P Inspection Information

Inspections Performed in Fiscal Years 2015 to 2019

Inspections Performed in Fiscal Years 2015 to 2019

Inspection Conclusion by Fiscal Year1

Inspection Conclusion by Fiscal Year
  2015 2016 2017 2018 2019
Inspections Classified NAI 501 541 561 529 440
Inspections Classified VAI 97 97 57 93 111
Inspections Classified OAI 8 5 8 12 12
Number of Inspections 598 636 621 625 563
Avg. hours per Inspection 34.4 38.1 36.9 37.8 41.3

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