How often does the FDA inspect drug manufacturing facilities?
The FDA inspects the nation’s approximately 3,000 domestic drug plants about once every two and a half years, according to a U.S. Government Accountability Office report published in September 2008. But the agency inspects only about 8 percent of foreign facilities in a given year, so that it would take more than 13 years to get to that group of plants, the GAO estimates. Overseas plants make ingredients for generic and brand-name drugs. An FDA spokeswoman says that the agency’s recently opened offices in India and China will “over time allow greater access for FDA inspections.” The FDA is beginning to collaborate with European countries and Australia to share inspection responsibilities.
