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Regulatory Focus™ > News Articles > FDA Releases Annual Report on Biological Product Deviations

FDA Releases Annual Report on Biological Product Deviations

Posted 28 June 2017 | By Michael Mezher 

FDA Releases Annual Report on Biological Product Deviations

The US Food and Drug Administration's (FDA) Center for Biologics Research and Evaluation (CBER) on Wednesday released its annual summary of manufacturing deviations reported by biologics, blood and blood component, and human cells, tissues, and cellular and tissue-based products (HCT/P) manufacturers.

During FY2016, CBER says it received 51,229 deviation reports that met its reporting threshold, a 10% increase from FY2015, but only slightly up from the 50,598 deviations reported in FY2014.

The vast majority of those reports came from blood and plasma manufacturers (50,319), with the rest coming from licensed biologics (651) and HCT/P manufacturers (259).

Nearly all of the increase is due to higher reporting from blood and source plasma establishments (4,546 more reports), while biologics manufacturers submitted only 93 more reports and HCT/P manufacturers submitted only three more reports than in the previous year.

The agency also says it saw an increase in the number of reporting establishments from 1,907 in FY2015 to 1,950 in FY2016, including three more allergenic product manufacturers, five more blood derivative manufacturers and five more in vitro diagnostic (IVD) manufacturers.

The report also goes into detail on the most commonly reported issues for non-blood products licensed by CBER, which include allergenic products, blood derivatives, IVDs, vaccines and licensed HCT/Ps.

Figure 1. Total Reports by Licensed Non-Blood Establishments (FY2014-FY2016)

CBER Deviation Table

Of the reports for licensed non-blood products, 50.7% pertained to products that did not meet specifications. Quality control and distribution issues accounted for 14.4% of reports, and other issues related to process controls, labeling, testing, and incoming material each accounted for less than 10% of reports.

For vaccines, which accounted for the highest number of reports in this category, FDA says it saw an increase in reports of products not meeting specification, most of which had to do with the product's appearance. FDA also says it saw an increase in reports for vaccine stability failures, broken or cracked vials in shipping and for equipment cleaning procedures, but noted a decrease in the number of reports relating to testing issues.

FDA also says it saw an uptick in the number of reports related to CBER-licensed IVDs, mostly related to unexpected reactions in testing, leaking vials or containers and products being received upside-down or on their side inside their shipping container.

For allergenic products, FDA says it received a similar number of reports compared to FY2015, 73% of which had to do with the discovery of a precipitate in an allergenic extract.


Tags: Deviations, CBER

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