The following are a list of biological CBER compliance programs:
Biologics
- 7341.002: Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
- 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
- 7345.848: Inspection of Biological Drug Products
Replaces 7342.006 – Inspection of Plasma Derivatives of Human Origin, 7345.001 – Inspection of Licensed Allergenic Products, 7345.002 – Inspection of Licensed Vaccines
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Content current as of:
06/12/2025
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Regulated Product(s)
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