The Food and Drug Administration’s annual summary
of biological product and human cells, tissues, and cellular and tissue-based product (HCT/P) deviation reports is now available for fiscal year 2020. FDA requires reporting of certain biological product deviations (BPD) and unexpected events in accordance with 21 CFR 600.14
. This summary provides an overview of the BPD reports received during fiscal year 2020, including detailed information regarding the number and types of reports received.
Overall, there was a 37.2% decrease in the number of BPDs reported in 2020 compared to 2019. Licensed blood establishments reported 6,057 fewer BPDs than in the previous year. Post-donation information (PDI) continued to be the most frequently reported BPD associated with the manufacture of blood (45.2%). These numbers represent a 53% decrease in the number of reports involving PDI in 2020 and reflect the March 2020 implementation of a revised BPD reporting guidance
in which the agency explained that it no longer considers post-donation information events to require BPD reports. For additional information on the March BPDR guidance, refer to AABB’s 2020 Ask the FDA transcript
. The most frequently reported BPD for unlicensed, registered blood establishments involved quality control and distribution, with 1,663 reports, representing a 2.2% increase from 2019.
Transfusion services submitted 22 more reports in 2020 than in 2019, with 56.1% of reports involving quality control and distribution. Source plasma reports reflected a 43% decrease, with 75.9% attributed to PDI.
Licensed 351 HCT/P manufacturers submitted 18 fewer reports than in 2019. Manufacturers of 361 HCT/Ps submitted 13 fewer reports in 2020 compared to 2019. The most frequently reported deviation for manufacturers of cellular 361 HCT/Ps involved receipt, pre-distribution, and shipment and distribution (83.8%).
Detailed information on BPD reports — including guidance documents on BPD reporting for blood and plasma establishments and licensed manufacturers of biological products other than blood and blood components — is available on FDA’s BPD web page
. FDA published a guidance
in 2017 for deviation reporting of 361 HCT/Ps that can be found on the tissue guidance web page
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