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Biological Deviation Reports May Spur ‘Direct’ Recall: CBER Officials

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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.
Drug GMP Report