Reports of Biologic Product Deviations

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