FDA Releases Annual Report on Biological Product Deviations

The United States Food and Drug Administration's (FDA) Center for Research and Evaluation of Organic Products (FDA) on Wednesday released its annual summary of manufacturing errors reported by organic products, blood and its components, human cells , Tissues and products based on cellular tissue and (HCT / P).

During the year 2016, CBER reported having received 51,229 diversion reports that reached its notification threshold, an increase of 10% compared with fiscal year 2015, only slightly up to 50 598 differences reported during 2014.

The vast majority of these reports were from blood and plasma manufacturers (50 319), with the remainder coming from authorized manufacturers of biologicals (651) and HCT / P (259).

Almost all of the increase is attributable to the higher proportions of plasma sources and blood transfusion centers (Additional Report 4545), while organic food manufacturers have submitted only 93 reports and additional HCT manufacturers / P only three reports have been submitted Over the previous year.

The agency also says it has seen an increase in the number of reporting institutions increasing from 1 907 to 2015 to 1950 with fiscal year 2016, including three other manufacturers of allergens, five other blood products and manufacturers five in vitro diagnostic manufacturers ( DIV).

The report also details issues most frequently for non-blood products authorized by CBER, which include allergen products, blood derivatives, IVD, vaccines, and HCT / Ps approved.

Among reports on products not allowed in the blood, 50.7% were for products that did not meet the specifications. Quality problems and distribution control accounted for 14.4% of reports, and other related issues for processing controls, labeling, testing and incoming material accounted for less than 10% of reports.

For vaccines, which accounted for the highest number of reports in this category, the FDA says that increased product ratios do not meet specifications, most of which relate to the appearance of the product. The FDA also claims to have seen an increase in reports of vaccine stability flaws, broken or cracked bottles in shipments and equipment cleaning procedures, but noted a decrease in the number of reports related to test problems.

The FDA also said that it recorded an increase in the number of reports related to DIV accredited CBER, mainly related to unexpected reactions in trials, bottle bottles or containers and products received upside down or on its side in its transport container.

For allergen products, the FDA claims to have received a similar number of reports compared to fiscal 2015, 73% involved the discovery of a precipitate in an allergen extract.