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  1. Compliance Actions (Biologics)

HCT/P Inspection Information

Inspections Performed in Fiscal Years 2017 to 2021

 

Bar graph showing Inspections Performed in Fiscal Years 2016 to 2020. Number of inspections in 2016: 636; Number of inspections in 2017: 621; Number of inspections in 2018: 625; Number of inspections in 2019: 563; Number of inspections in 2020: 287

Inspection Conclusion by Fiscal Year

Inspection Conclusion by Fiscal Year
  2017 2018 2019 2020 2021
Inspections Classified NAI 561 529 440 236 111
Inspections Classified VAI 57 93 111 40 44
Inspections Classified OAI 8 12 12 8 4
Number of Inspections1 621 625 563 287 159

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.

[1]Sum of inspection classifications does not equal total number of inspections performed by fiscal year due to data constraints.

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