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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

(301) 827-6220
Biological Product Deviation Reporting (CBER)

Director, Office of Compliance and Biologics Quality (HFM-600)

Center for Biologics Evaluation and Research

Food and Drug Administration

1401 Rockville Pike, Suite 200N

Rockville, MD 20852-1448