Most FDA Offices Overseas Don’t Have Device Experts

The U.S. Food and Drug Administration’s overseas offices are lacking device facility inspection experts, according to Murray Lumpkin, the agency’s deputy commissioner for international programs, who spoke at the annual GMP by the Sea conference.

The agency and the State Department are hoping to have an office open in the Middle East before Oct. 1, and a Mexico City Office is slated to be staffed by Nov. 1; however, neither of these facilities will have device experts, said Lumpkin.

If an emergency with a device manufacturer were to occur outside the United States, the problem would be referred to the Center for Devices and Radiological Health, Edwin Rivera-Martinez, chief of the international compliance branch in the Center for Drug Evaluation and Research division of manufacturing and compliance, said at the conference.

Overseas staffers’ responsibility is primarily to learn about the regulatory process in those countries and work with local inspectors, he added.