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

• 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
• Submitting Medical Device Reports (MDRs) to CBER for Devices Licensed as Biological Products

Recalls

• Recalls, Market Withdrawals, & Safety Alerts
  FDA-wide Recalls
• 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.

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

Inspections

• Compliance Programs (CBER)
• Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) Inspection Information
• Clinical Investigator Status (Biologics)

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

• Administrative Actions (Biologics)

Follow CBER

Division of Communication and Consumer Affairs
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

ocod@fda.hhs.gov

(800) 835-4709
(240) 402-8010

For Updates on Twitter, follow @fdacber

• Resources for You (Biologics)
• About the Center for Biologics Evaluation and Research (CBER)
• Report a Problem to the Center for Biologics Evaluation & Research
• Recalls (Biologics)
• CBER-Regulated Products: Shortages and Discontinuations
• Biologics Products & Establishments