Therapeutic
Biological Products
Mailing Address for Reports of Biologic Product Deviations
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 |