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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Biological Product Deviation Guidances & Rules

You may find the following information helpful.


Contact FDA

(240) 402-9160
Biological Product Deviation Reporting (CBER)

U.S. Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center

10903 New Hampshire Avenue
Building 71, Room G112
Silver Spring, MD 20993-0002