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                Compliance Actions (Biologics)

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    PrintInspections 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
			2022Inspections Classified NAI
			529
			440
			236
			111
			295Inspections Classified VAI
			93
			111
			40
			44
			73Inspections Classified OAI
			12
			12
			8
			4
			11Number 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.

                                                                                  Content current as of:
      05/10/2023
              
              
Regulated Product(s)
		 BiologicsCompliance Actions (Biologics)

          
                        


                        Administrative Actions (Biologics)
          Enforcement Actions (CBER)
          Exporting CBER-Regulated Products
          Product Surveillance (CBER)
 
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