About This File
- Docket Number: FDA-2001-D-0007
- Issued by: Center 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.