ARTICLES BY BARBARA UNGER
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![compliance-regulations]( "An Analysis Of FDA’s 2017 Enforcement Action Statistics")
An Analysis Of FDA’s 2017 Enforcement Action Statistics3/5/2018FDA's recently published enforcement statistics for FY2017 provide a high-level overview of enforcement actions — including injunctions, seizures, warning letters, and recalls — conducted by all FDA Centers. This article examines the general data from all Centers and then delves into metrics specific to CDRH.
Barbara Unger
Barbara Unger formed Unger Consulting, Inc. in December 2014 to provide GMP auditing and regulatory intelligence services to the pharmaceutical industry. She has extensive expertise in this area having developed, implemented, and maintained the GMP regulatory intelligence program for eight years at Amgen Inc. This included surveillance, analysis, and communication of GMP related legislation, regulations, guidance, and industry compliance enforcement trends. Barbara was the first chairperson of the Rx-360 Monitoring and Reporting work group (2009 to 2014) that summarized and published relevant GMP and supply chain related laws, regulations, and guidance. She also served as the chairperson of the Midwest Discussion Group GMP-Intelligence sub-group from 2010 to 2014.
Before Amgen, Barbara worked for the consulting firm Don Hill and Associates, providing regulatory and quality services to the pharmaceutical industry, and for Eli Lilly and Company in quality and CMC regulatory affairs positions. She began her career in the pharmaceutical / device industry with Hybritech Inc. and received a bachelor's degree in chemistry from the University of Illinois in Urbana Illinois.