All reports of biologic product deviations required by 21 CFR 600.14 should be sent to:

Division of Compliance Risk Management and Surveillance (HFD-330)
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane 
Rockville, MD 20857

Biological product deviations sent by courier or overnight mail should be addressed to:

Food and Drug Administration, CDER
Office of Compliance
Division of Compliance Risk Management and Surveillance
10903 New Hampshire Ave. Bldg. 51, Rm 4203
Silver Spring, MD 20993-0002

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Date created: October 29, 2003, Updated, February 19, 2008