FDAnews Drug Daily Bulletin

eBPDRs May Trigger Recalls, CBER Officials Say

Aug. 20, 2012
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Now that CBER’s all-electronic Direct Recall Classification (DRC) program has been extended to non-blood products, problems with biologic drugs flagged in electronic biological product deviation reports (eBPDRs) may trigger recalls of those products under the program. No such recalls have yet been triggered, as the DRC system is not yet capable of processing eBPDR reports for non-blood products, Sharon O’Callaghan, a CBER compliance and quality officer and manager of the center’s eBPDR program, said.
Washington Drug Letter