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GUIDANCE DOCUMENT

Biological Product Deviation Reporting for Blood and Plasma Establishments Guidance for Industry October 2006

Final

Biological Product Deviation Reporting for Blood and Plasma Establishments

Docket Number:
2001D-0220
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance document provides you, a blood or plasma establishment, with the FDA's current thinking related to the biological product deviation (BPD) reporting requirements. For the purposes of this document, “blood and plasma establishment” includes licensed manufacturers of blood and blood components, including Source Plasma, unlicensed registered blood establishments, and transfusion services. This guidance document finalizes the draft guidance of the same title dated August 2001.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2001D-0220.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010