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.