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Vaccines, Blood & Biologics
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Resources for You
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Biological Product Deviation Guidances & Rules
You may find the following information helpful.
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Publications
- Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments
10/2006 - Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components
10/2006 - Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement; Final Rule
11/24/2004 - Biological Products: Reporting of Biological Product Deviations in Manufacturing (Final Rule)
11/7/2000
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Contact Us
Biological Product Deviation Reporting (CBER)
- (301) 827-6220
- bp_deviations@fda.hhs.gov
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
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