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Vaccines, Blood & Biologics
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Resources for You
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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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Adverse Events and Product Deviations
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Recalls
- Recalls, Market Withdrawals, & Safety Alerts
FDA-wide Recalls - Recalls (Biologics)
Recalls from the Center for Biologics Evaluation and Research - FDA 101: Product Recalls - From First Alert to Effectiveness Checks
FDA Consumer Update
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Inspections
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Regulatory Actions Issued by CBER
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Administrative Actions Issued By CBER
- Administrative Actions (Biologics)
Notice of Intent to Revoke (NOIR), List of HCT/P Orders
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Contact Us
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
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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