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News and Guidelines

March 19, 2020

COVID-19 Procedure

Today, the U.S. Food and Drug Administration took a step towards ensuring the accuracy of its inventory of importers responsible for meeting the requirements of the Foreign Supplier Verification Programs (FSVP) rule.
March 6, 2020

Third Party Audit Guidance FDA

This guidance is intended to assist industry and the Food and Drug Administration (FDA) staff by recommending standards
December 3, 2019

How do I interpret an import alert?

If your product is detained without physical examination, you have the right to provide evidence to FDA in an attempt to overcome the appearance of the violation. If you do not provide evidence to FDA, or if the information you provide is not sufficient to overcome the appearance of the violation, your product is subject to refusal into the United States. Visit the Detention and Hearing page for more information on this process.
November 2, 2019

Recall FDA

The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products.