The FDA needs to strengthen its foreign drug inspection program with better data management and by conducting more inspections, GAO has said after analyzing FDA information, reviewing inspection reports and interviewing agency officials.
FDA databases contain inaccurate information on foreign establishments subject to inspection, according to GAO-08-970.
It said the agency uses information from a database of establishments registered to market drugs in the United States and a database of establishments that shipped drugs to the United States to compile a list of establishments subject to inspection, but said these databases contain divergent estimates of about 3,000 and 6,800.
FDA’s registration database contains information about establishments not subject to FDA inspection, and although annual re-registration is required, FDA does not deactivate in its database establishments that do not fulfill this requirement, GAO said.
It said the agency also does not routinely verify that a registered establishment manufactures a drug for the U.S. market, adding that the accuracy of this information is important in FDA’s identification of foreign establishments subject to inspection.
