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Food and Drug Administration: Improvements Needed in the Foreign Drug Inspection Program

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Report Type Reports and Testimonies
Report Date March 17, 1998
Report No. HEHS-98-21
Subject
Summary:

As much as 80 percent of bulk pharmaceutical chemicals used by U.S. manufacturers to produce prescription drugs is imported. Although the Food and Drug Administration (FDA) has taken steps to address problems with its foreign inspection program, it conducts infrequent inspections of foreign manufacturers to ensure that they comply with U.S. quality control standards. Routine surveillance inspections of foreign pharmaceutical manufacturers occur with far less frequency than the two-year interval required for domestic manufacturers. In China and India, for example, as long as five years has elapsed between FDA inspections of drug manufacturers. Moreover, FDA is still experiencing delays in taking enforcement action against foreign pharmaceutical manufacturers. In one case, FDA allowed a manufacturer in India to continue exporting its products to the United States despite an investigator's finding that the manufacturer could not adequately test for impurities in its product and water system. Nearly two years passed before FDA determined that enforcement action had never been taken against this manufacturer.

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