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        Guidance, Compliance & Regulatory Information (Biologics)

Compliance Actions (Biologics)

                        
                


                Administrative Actions (Biologics)
          Enforcement Actions (CBER)
          Exporting CBER-Regulated Products
          Product Surveillance (CBER) Home
          Vaccines, Blood & Biologics
          Guidance, Compliance & Regulatory Information (Biologics)
          Compliance Actions (Biologics)Guidance, Compliance & Regulatory Information (Biologics) Compliance Actions (Biologics)
  	
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    PrintCBER carries out a wide range of compliance and surveillance activities during the "life cycle" of biological products, including:

Conducting pre-license and pre-approval inspections of manufacturing facilities and products under clinical study.
	Monitoring the safety, purity and potency of biological products through review of:
	Biological Product Deviation Reports (BPDRs) and HCT/P Deviation Reports,
		Investigations into transfusion and donation related fatalities and other adverse events,
		Product recalls.
	Monitoring reports of biological product shortages.
	Initiating regulatory action to address non-compliance with FDA laws and regulations.
	Monitoring of research conducted on biological products and assessing the protection of the rights, safety, and welfare of human research subjects and the quality and integrity of research data.
	Monitoring import and export activities.
	Reviewing product advertising and promotional labeling.Adverse Events and Product Deviations

Biological Product Deviations
	Vaccine Adverse Events
	Biological Product Deviation Reports Annual Summaries
	Transfusion/Donation Fatalities
	Report a Problem to the Center for Biologics Evaluation & Research
	Submitting Medical Device Reports (MDRs) to CBER for Devices Licensed as Biological ProductsRecalls

Recalls, Market Withdrawals, & Safety Alerts
	FDA-wide Recalls
	Recalls (Biologics)
	Recalls from the Center for Biologics Evaluation and Research
	Enforcement Reports
	The FDA Enforcement Report is published weekly. It contains information on actions taken in connection with agency Regulatory activities.
	FDA 101: Product Recalls
	FDA Consumer UpdateProduct Safety & Availability

Safety & Availability (Biologics)
	Recalls, Shortages, Biological Product Deviation Reporting, Adverse Event Reporting, HIV Home Test Kits
	CBER-Regulated Products: Shortages and Discontinuations
	Counterfeit MedicineInspections

Compliance Programs (CBER)
	Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) Inspection Information
	Clinical Investigator Status (Biologics)Regulatory Actions Issued by CBER

Regulatory Actions Issued by CBER
	Search Warning Letters and Responses with Search Form
	BIMO/Team Biologics/Internet Surveillance/Other
	Untitled Letters Regarding Advertising & Promotional Labeling for Approved BiologicsAdministrative Actions Issued By CBER

Administrative Actions (Biologics)Sub-Topic Paragraphs
          Follow CBER
		Division of Communication and Consumer Affairs
			Office of Communication, Outreach and Development
			Center for Biologics Evaluation and Research
			Food and Drug Administration
			10903 New Hampshire Ave WO71-3103
			Silver Spring, MD 20993-0002
		
		ocod@fda.hhs.gov
		
		(800) 835-4709
			(240) 402-8010
		
		For Updates on Twitter, follow @fdacber
	Resources for You (Biologics)
			About the Center for Biologics Evaluation and Research (CBER)
			Report a Problem to the Center for Biologics Evaluation & Research
			Recalls (Biologics)
			CBER-Regulated Products: Shortages and Discontinuations
			Biologics Products & Establishments

                                                                                  Content current as of:
      09/15/2021
                  
                   
Regulated Product(s)
		 BiologicsTopic(s)
			  Application & ApprovalsCompliance Actions (Biologics)                
                          

                        


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