Biologics

• 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
• 7342.007 - Imported CBER-Regulated Products
• 7342.007 Addendum - Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps)
• 7342.008 - Inspection of Licensed In-Vitro Diagnostic (IVD) Devices Regulated by CBER
• 7345.848 - Inspection of Biological Drug Products (PDF - 570KB)
  Replaces 7342.006 - Inspection of Plasma Derivatives of Human Origin, 7345.001 - Inspection of Licensed Allergenic Products, 7345.002 - Inspection of Licensed Vaccines