Biological and Blood Product Deviation Reports Up

CBER’s Office of Compliance and Biologics Quality/Division of Inspections and Surveillance says it entered 51,229 deviation reports into the Biological Product Deviation database in FY 2016, up 10% from the number of reports entered in FY 15. Blood and source plasma establishments submitted 4,546 more reports in FY 16 compared to FY 15, the annual summary says. Manufacturers of licensed biological products other than blood and blood components submitted 93 more reports in FY 16 compared to FY 15.

The summary says the total number of reporting establishments increased from 1,907 in FY 15 to 1,950 in FY 16.

The report lists the types of manufacturers required to submit a biological product deviation report if the safety, purity, or potency of a distributed product may be affected. CBER recommends that each firm responsible for reporting biological product deviations use the information in the summary to evaluate their own deviation management programs.