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.