REGULATORY UPDATE: FDA Releases 2021 Biological Product Deviation Report Summary

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 2021. 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 between Oct. 1, 2020, and Sept. 30, 2021, including detailed information regarding the number and types of reports received.

Overall, there was a 52.9% decrease in the number of BPDs reported in 2021 compared with 2020. According to FDA, this decrease is a result of the implementation of the March 2020 BPD guidance that eliminated reporting of post-donation information. The total number of reporting establishments in increased from 2,133 in 2020 to 2,152 in 2021 (28 more blood and source plasma establishments, four fewer manufacturers of licensed biological products other than blood and blood components, and one more 361 HCT/P manufacturer reporting in 2021).

Licensed blood establishments reported 3,535 fewer BPDs than in the previous year, a 36% decrease.
During 2021, the most frequently reported BPD associated with the manufacture of blood involved quality control (QC) and distribution (32.4%), followed by blood collection (30.4%) and donor screening (24.8%). Among unlicensed, registered blood establishments, the most frequently reported BPD also involved QC and distribution (61.7%).

Transfusion services submitted 47 more reports in 2021 than in 2020 (a 3% increase), with 54.3% of reports involving quality control and distribution. Source plasma reports reflected 12,512 fewer reports, an 80% decrease, with 88% attributed to QC and distribution.

Licensed 351 HCT/P manufacturers submitted three fewer reports than in 2020 (a 9% decrease). Of these reports, 37.9% were related to product labeling. Manufacturers of 361 HCT/Ps also submitted 14 more reports in 2021 compared to 2020, a 7% increase. The most frequently reported deviation for manufacturers of cellular 361 HCT/Ps involved receipt, pre-distribution, and shipment and distribution (75%).

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.