FDA drug, device import refusals rise due to improper registration

The number of foreign drug and medical devices the U.S. Food and Drug Administration refuses to import has increased exponentially from 2012 to 2013, according to a news release from Registrar Corp, an FDA consulting firm.

In 2012, the FDA issued 28 refusals. In 2013, that number jumped to 806 refusals, according to the report. Additionally, more than 20 percent of the import refusals in 2013 were issued because the drug was unlisted or unapproved.

Foreign drug and device manufacturers are required to register with the FDA indicating a U.S. agent and a list of all the drugs and devices intended for use. The majority of import refusals are due to unregistered foreign manufacturers, according to the report.

"It's clear to us that FDA is increasing enforcement on these types of products," said David Lennarz, Registrar Corp vice president, in the news release. "It is prudent for companies to make sure they comply before starting or continuing to export to the United States."

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