The CBER’s annual summary signals a moderate increase in deviation reports, with blood and source plasma establishments accounting for the majority. Post-donation information was commonly cited in blood and source plasma reports, whereas product specifications were a frequent issue in non-blood product reports.

The Center for Biologics Evaluation and Research (CBER) published its annual summary for FY2016 of deviation reports by manufacturers of biologics; blood and blood components; and human cells, tissues, and cellular and tissue-based products (HCT/Ps). The Office of Compliance and Biologics Quality’s Division of Inspections and Surveillance received a total of 51,229 deviation reports in FY2016, representing a 10% increase over FY2015, though the number doesn’t account for reports that didn’t meet reporting thresholds. There was a slight increase in the number of reporting establishments, from 1,907 in FY2015 to 1,950 in FY2016.

Blood and source plasma establishments accounted for a large portion of the increase (4,546 more reports compared to FY2015) and 98% of the total reports in FY2016. Source plasma establishments were primarily responsible for the increase, accounting for 3,930 more reports and representing 52% of the blood and source plasma reports. The most frequently reported event among blood and source plasma manufacturers was post-donation information (PDI), which accounted for 71% of the deviation reports. Among licensed blood establishments, 69.5% of reports involved PDI, and just 6.5% involved quality control and distribution deviations or unexpected events. In contrast, quality control and distribution deviations and unexpected events accounted for 56.1% of reports by unlicensed registered blood establishments, labeling accounted for 22.6% and PDI accounted for just 9.1%.

There was only a slight uptick (93) in the number of reports by manufacturers of licensed biological products other than blood and blood components, with 651 total reports. In all, product specifications accounted for slightly more than half (50.7%) of the reports, while quality control and distribution accounted for 14.4%, process control accounted for 9.8% and labeling accounted for 8.8%.

  • Vaccine manufacturers accounted for 42 of the 93 additional reports and 265 of the total reports. Of these, 103 reports involved product specifications and 46 involved quality control and distribution, including 35 reports of broken or cracked vials.
  • Licensed in vitro diagnostic manufacturers were responsible for 33 more reports in FY2016, for a total of 144. A large portion of these reports (97) related to product specifications, including 61 reports of unexpected reactions in testing and 15 reports of leaking vials or other containers.
  • A total of 351 licensed HCT/P manufacturers submitted the same number of reports as in FY2015 (19 total). There was an increase in the number of reports related to labeling controls among licensed HCT/P manufacturers, from eight in FY2015 to 14 in FY2016, primarily involving products labeled with the wrong recipient identification.

Manufacturers of 361 HCT/Ps submitted three more reports in FY2016 than in FY2015, for a total of 259, including 135 by cellular HCT/P manufacturers and 125 by tissue HCT/P manufacturers. The most commonly reported issues related to processing and processing controls (34%); receipt, pre-distribution, shipment and distribution (22.8%); and donor eligibility (20.5%). The number of reports involving contamination or potential contamination during processing in FY2016 was similar to the number in FY2015, whereas the number of reports related to distribution of contaminated products declined in FY2016.