Compliance and Surveillance

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

Adverse Events and Product Deviations

Product Safety

Imports and Exports


Regulatory Actions Issued by CBER

Updated: November 20, 2008