FDA Increases Drug and Medical Device Imports Refusal Due to Improper Registration

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FDA reports an increase in the number of import refusals due to drug and medical device manufacturers being improperly registered and products being unlisted. Registrar Corp, an FDA compliance firm, comments on the registration process.

FDA Import Refusals
'It’s clear to us that FDA is increasing enforcement on these types of products,' said Registrar Corp Vice President David Lennarz.

The U.S. Food and Drug Administration (FDA) continues to refuse an increasing number of imports due to non-registered drug and medical device manufacturers and unlisted or unapproved drugs.[1]    

FDA requires foreign drug and medical device manufacturers to register with the FDA before exporting products to the United States. At the time of registration, foreign facilities must identify a U.S. agent and list all drugs or devices intended for use in the United States.

“Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic or foreign firms must at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Foreign establishments must identify a U.S. agent at the time of their registration.”

“It’s clear to us that FDA is increasing enforcement on these types of products,” said Registrar Corp Vice President David Lennarz. “It is prudent for companies to make sure they comply before starting or continuing to export to the United States.”

The number of drug and device refusals due to unregistered foreign manufacturers increased from 28 refusals in 2012 to 806 refusals in 2013. Along with this, over 20% of import refusals in 2013 were due to drugs being unlisted or unapproved. If you are concerned about your products being refused entry into the U.S. for any of these reasons Registrar Corp can help.

Registrar Corp is an FDA consulting firm that helps companies with U.S. FDA regulations. Registrar Corp’s regulatory specialists can properly renew a facility’s registration and handle a foreign facility’s FDA communications professionally as its U.S. Agent. Registrar Corp also offers product and label review services for both drugs and medical devices that can help prevent import refusals due to non-compliance. If you need assistance with any of these procedures, contact Registrar Corp at 1-757-224-0177 or receive online Live Help from our regulatory specialists: http://www.registrarcorp.com/livehelp.

[1] http://www.accessdata.fda.gov/scripts/importrefusals/

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David Lennarz

Liviana Callahan
since: 08/2010
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