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Vaccines, Blood & Biologics
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Resources for You
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Compliance Programs (CBER)
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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 Viral Marker Test Kits
- 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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Contact Us
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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