• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

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