REGULATORY UPDATE: FDA Releases 2022 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 2022. 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, 2021, and Sept. 30, 2022, including detailed information regarding the number and types of reports received.

Overall, there were 15,010 BPD reports submitted in 2022, a 3% increase compared with 2021 (14,556). The total number of reporting establishments increased from 2,152 in 2021 to 2,276 in 2022. This increase includes 105 blood and source plasma establishments, 14 manufacturers of licensed biological products other than blood and blood components and five 361 HCT/P manufacturers reporting in 2022.

Licensed blood establishments reported 6,131 BPDs in 2022, a 1.7% decrease compared with 2021 (6,234). Unlicensed blood establishments reported 2,429 BPDs, a 6.2% decrease from 2021 (2,589). Among licensed establishments, the most frequently reported BPDs associated with the manufacture of blood involved quality control (QC) and distribution (38%), followed by blood collection (29.1%) and donor screening (18.2%). Among unlicensed registered blood establishments, the most frequently reported BPD also involved QC and distribution (60.2%).

Transfusion services submitted 43 more reports in 2022 than in 2021 (a 2.3% increase), with 54.3% of reports involving quality control and distribution. Source plasma reports increased by 682 (21.5%) between 2021 and 2022, with 89.2% attributed to QC and distribution.

Licensed 351 HCT/P manufacturers submitted four more reports than in 2021 (a 19% increase). Of these reports, 80% were related to product labeling. Manufacturers of cellular 361 HCT/Ps submitted two fewer reports in 2022 (a 1.5% decrease). The most frequently reported deviation for manufacturers of cellular 361 HCT/Ps involved receipt, pre-distribution, and shipment and distribution (67.9%). Gene therapy product manufacturers reported 18 BPDs (a 125% increase compared with 2021), with the most frequently reported BPDs associated with product specifications (33.3%).

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 is available on the tissue guidance web page.

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