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
Recalls, Market Withdrawals, & Safety Alerts[ARCHIVED]
Recalls from the Center for Biologics Evaluation and Research
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 Update
Product 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 Medicine
Regulatory Actions Issued by CBER
Administrative Actions Issued By CBER
Administrative Actions (Biologics) Notice of Intent to Revoke (NOIR), List of HCT/P Orders