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  1. Compliance Actions (Biologics)

Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) Inspection Information

Inspections Performed in Fiscal Years 2018 to 2022

Bar graph showing Inspections Performed in Fiscal Years 2018 to 2022. Number of inspections in 2018: 625; Number of inspections in 2019: 563; Number of inspections in 2020: 287; Number of inspections in 2021: 159; Number of inspections in 2022: 379

Inspection Conclusion by Fiscal Year

Inspection Conclusion by Fiscal Year
  2018 2019 2020 2021 2022
Inspections Classified NAI 529 440 236 111 295
Inspections Classified VAI 93 111 40 44 73
Inspections Classified OAI 12 12 8 4 11
Number of Inspections1 625 563 287 159 379

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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