Report: FDA Yet to Inspect One-Third of Foreign Drug Plants

Although federal authorities increased their oversight of overseas pharmaceutical manufacturing plants in recent years, an audit indicated that substantial numbers still have yet to be inspected.

Chemical & Engineering News reports that the Government Accountability Office audit found more than 1,000 facilities that export pharmaceuticals to the U.S. but were never inspected by regulators as of mid-2016.

That total included 45 percent of facilities in China that export to the U.S., 33 percent in India and 90 percent in South Korea.

The report, however, also noted that the percentage of plants inspected by the Food and Drug Administration climbed from just one-third in 2010 to two-thirds as of June.

The agency anticipated inspecting the remainder with three years, but CE&N noted that goal preceded a federal hiring freeze instituted by the Trump administration last week.

The FDA prioritizes which plants to inspect based on the risk that they could pose, and an industry consultant told the publication that those plants that were not inspected likely make over-the-counter drugs.

“There is a risk that the OTC drugs will not work," said Peter Saxon of Saxon International Associates. "But if they are adequately tested when they arrive in the U.S., then the risk is low."