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Guidance Issuing OfficeCenter for Biologics Evaluation and Research
We, FDA, are providing you, a blood or plasma establishment, with revised recommendations related to biological product deviation (BPD) reporting. This guidance document is intended to assist blood and plasma establishments in determining when a report is required, who submits the report, what information to submit in the report, the timeframe for reporting, and how to submit the report. The revised guidance explains that we do not consider post donation information (PDI) events to require BPD reports.
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2001-D-0007.