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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Compliance Actions (Biologics)

CBER 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.
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Recalls

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Product Safety & Availability

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Administrative Actions Issued By CBER

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Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448
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