Compliance Programs

• 7341.002 - Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
      (covers HCT/Ps recovered after 5/25/2005)
• 7341.002A - Inspection of Tissue Establishments
      (covers human tissue recovered before 5/25/2005)
• 7342.001 - Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors
• 7342.002 - Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors
• 7342.006 - Inspection of Plasma Derivatives of Human Origin - replaced by 7345.848
• 7342.007 - Imported CBER-Regulated Products
• 7342.007 Addendum - Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps)
• 7342.008 - Inspection of Licensed Viral Marker Test Kits
• 7345.001 - Inspection of Licensed Allergenic Products - replaced by 7345.848
• 7345.002 - Inspection of Licensed Vaccines - replaced by 7345.848
• 7345.848 - Inspection of Biological Drug Products
• Compliance Program Guidance Manual - Office of Regulatory Affairs
• Compliance Policy Guides Manual - Office of Regulatory Affairs

CBER Information

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