REGULATORY UPDATE: FDA Releases 2023 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 2023.

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, 2022, and Sept. 30, 2023, including detailed information regarding the number and types of reports received.

Overall, there were 16,258 BPD reports submitted in 2023, an 8.3% increase from 2022 (15,010). The total number of reporting establishments increased from 2,276 in 2022 to 2,475 in 2023. This reflects an increase of 203 blood and source plasma establishments, 10 fewer manufacturers of licensed biological products other than blood and blood components, and six more 361 HCT/P manufacturers reporting in 2023.

Licensed blood establishments reported 5,864 BPDs in 2023, a 4.4% decrease compared with 2022 (6,131). Unlicensed blood establishments reported 2,637 BPDs, an 8.6% increase from 2022 (2,429). Among licensed establishments, the most frequently reported BPDs associated with the manufacture of blood involved quality control (QC) and distribution (41.4%), followed by blood collection (25.3%) and donor screening (18.4%). Among unlicensed registered blood establishments, the most frequently reported BPD also involved QC and distribution (60.9%).

Transfusion services submitted 2,173 reports in 2023 (a 15.9% increase from 2022), with 55% of reports involving quality control and distribution. Source plasma reports increased from 3,848 in 2022 to 4,904 in 2023 (27.4%), with 89.2% attributed to QC and distribution.

Licensed 351 HCT/P manufacturers submitted 18 reports in 2023 (a 28% decrease from 25 in 2022). Of these reports, 33.3% were related to product labeling. Manufacturers of cellular 361 HCT/Ps submitted the same number of reports in 2022 and 2023 (134). The most frequently reported deviation for manufacturers of cellular 361 HCT/Ps involved receipt, pre-distribution, and shipment and distribution (74.6%). Gene therapy product manufacturers reported 18 BPDs (the same number as in 2022), with the most frequently reported BPDs associated with testing (50%).

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.