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In this section: Enforcement Actions (CBER)

Compliance Programs (CBER)

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)
7341.002A: Inspection of Tissue Establishments
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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