REGULATORY UPDATE: FDA Releases 2020 Biological Product Deviation Report Summary

April 13, 2021

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, 606.171 or 1271.350(b). 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.

For additional information, please contact regulatory@aabb.org.