Drug Safety: Preliminary Findings Indicate Persistent Challenges with FDA Foreign Inspections, Statement of Mary Denigan-Macauley Director, Health Care, Testimony Before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives [open pdf - 734KB]
From the GAO [Government Accountability Office] Highlights: "More than 60 percent of establishments manufacturing drugs for the U.S. market were located overseas in fiscal year 2018. FDA has estimated that about 40 percent of finished drugs and 80 percent of active drug ingredients are manufactured overseas. FDA is responsible for overseeing the safety and effectiveness of all drugs marketed in the United States, regardless of where they are produced and conducts inspections of both foreign and domestic drug manufacturing establishments. GAO has had long-standing concerns about FDA's ability to oversee the increasingly global supply chain, an issue highlighted in GAO's High Risk Series for the last 10 years. GAO recommended in 2008 (GAO-08-970) that FDA increase the number of inspections of foreign drug establishments. GAO found in 2010 (GAO-10-961) and 2016 (GAO-17-143) that FDA was conducting more of these foreign drug inspections, but GAO also reported that FDA may have never inspected many establishments manufacturing drugs for the U.S. market."
Government Accountability Office: https://www.gao.gov/