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                Compliance Actions (Biologics)

Compliance Actions (Biologics)

                        


                        Administrative Actions (Biologics)
          Enforcement Actions (CBER)
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          Guidance, Compliance & Regulatory Information (Biologics)
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          Clinical Investigator Status (Biologics)Compliance Actions (Biologics) Clinical Investigator Status (Biologics)
  
  	
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    PrintInspections of clinical investigators who have conducted studies with investigational devices reviewed by CBER are carried out as part of the Food and Drug Administration's Bioresearch Monitoring Program. The Clinical Investigator Inspection List contains information on such inspections that were closed after 1989. The list will be updated quarterly.

A Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE letter) is issued when FDA believes it has evidence that the clinical investigator repeatedly or deliberately violated FDA's regulations governing the proper conduct of clinical studies involving investigational products or submitted false information to the sponsor.

Clinical Investigator Inspection List

Updated through 12/31/2023

Clinical Investigator Inspection List A-D
	Clinical Investigator Inspection List E-K
	Clinical Investigator Inspection List L-P
	Clinical Investigator Inspection List Q-S
	Clinical Investigator Inspection List T-Z

                                                                                  Content current as of:
      01/11/2024
              
              
Regulated Product(s)
		 BiologicsTopic(s)
			  InspectionCompliance Actions (Biologics)

          
                        


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