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                Enforcement Actions (CBER)

Enforcement Actions (CBER)

                        Compliance Programs (CBER)
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          Vaccines, Blood & Biologics
          Guidance, Compliance & Regulatory Information (Biologics)
          Compliance Actions (Biologics)
          Enforcement Actions (CBER)
          Compliance Programs (CBER)Enforcement Actions (CBER) Compliance Programs (CBER)
  
  	
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    PrintThe following are a list of biological CBER compliance programs:

Biologics

7341.002: Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
	7341.002A: Inspection of Tissue Establishments
	7342.001: Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors
	7342.002: Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors
	7342.007: Imported CBER-Regulated Products
	7342.007 Addendum: Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps)
	7342.008: Inspection of Licensed In-Vitro Diagnostic (IVD) Devices
	7345.848: Inspection of Biological Drug Products
	Replaces 7342.006 - Inspection of Plasma Derivatives of Human Origin, 7345.001 - Inspection of Licensed Allergenic Products, 7345.002 - Inspection of Licensed Vaccines

                                                                                  Content current as of:
      03/28/2019
              
              
Regulated Product(s)
		 BiologicsTopic(s)
			  Application & ApprovalsEnforcement Actions (CBER)

          
                        Compliance Programs (CBER)
          Untitled Letters (CBER)
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