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.
Adverse Events and Product Deviations
- Biological Product Deviations
- Vaccine Adverse Events
- Biological Product Deviation Reports Annual Summaries
- Transfusion/Donation Fatalities
- Report a Problem to the Center for Biologics Evaluation & Research
- Recalls, Market Withdrawals, & Safety Alerts
- Recalls (Biologics)
Recalls from the Center for Biologics Evaluation and Research
- Enforcement Reports
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
- Regulatory Actions Issued by CBER
- Search Warning Letters and Responses with Search Form
- BIMO/Team Biologics/Internet Surveillance/Other
- Untitled Letters Regarding Advertising & Promotional Labeling for Approved Biologics
Administrative Actions Issued By CBER
- Resources for You
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002
White Oak Campus
10903 New Hampshire Ave
Silver Spring, MD 20993
For Updates on Twitter follow
The latest information from the Center for Biologics Evaluation and Research.