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                Enforcement Actions (CBER)

Enforcement Actions (CBER)

                        Compliance Programs (CBER)
          Untitled Letters (CBER) Home
          Vaccines, Blood & Biologics
          Guidance, Compliance & Regulatory Information (Biologics)
          Compliance Actions (Biologics)
          Enforcement Actions (CBER)
          Untitled Letters (CBER)Enforcement Actions (CBER) Untitled Letters (CBER)
  
  	
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    PrintAn Untitled Letter is an initial correspondence with regulated industry that cites violations that do not meet the threshold of regulatory significance for a Warning Letter. Examples when CBER has issued an Untitled Letter include after its review of a manufacturer's advertising and promotional labeling, after an inspection under CBER's bioresearch monitoring program or by Team Biologics, and as a result of internet website surveillance.

Key Resources

BIMO/Team Biologics/Internet Surveillance/Other
	Untitled Letters Regarding Advertising & Promotional Labeling for Approved Biologics

                                                                                  Content current as of:
      03/28/2019
              
              
Regulated Product(s)
		 BiologicsEnforcement Actions (CBER)

          
                        Compliance Programs (CBER)
          Untitled Letters (CBER)
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