Warning Letter Archives | Customs & International Trade Law Blog

Food Importers: How to Import Food Compliantly & Survive a FSVP Audit

The U.S. Food and Drug Administration (FDA) is now auditing Foreign Supplier Verification Program (FSVP) Importers to ensure they comply with the FSVP program. To date, over 92 warning letters have been issued against companies for FSVP violations. If your business is importing food into the U.S., or wants to start, our one-hour, NEI accredited, webinar on “Importing Food in Compliance with U.S. FDA & Surviving A FSVP Audit” will provide best practices and TOP tips to comply with FDA regulations and avoid, navigate, and mitigate any potential FDA compliance action.

Register today to to hear directly from Senior Trade Advisor, Domenic Veneziano, DTL’s president, Jennifer Diaz, and Associate Attorney, Denise Calle, on the pathway to legally import food and best practices for surviving a FSVP audit.

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By Jennifer Diaz|2021-09-07T15:53:46-04:00September 6, 2021|Best Practices, Food, Import, International Trade, Labeling, Pre-compliance, U.S. Food and Drug Administration (FDA)|Comments Off

Don’t Let FDA Target Your Medical Device Company

Did you know FDA has issued 1,569 enforcement actions against medical device companies? Now is the time to ensure your medical devices are in compliance with FDA laws and regulations prior to importation. If your business is manufacturing, repackaging, relabeling, and/or importing medical devices into the U.S., or wants to start, our one-hour webinar on “Importing Medical Devices in Compliance with U.S. FDA” is for you. We will provide TOP tips to avoid U.S. Food and Drug Administration (FDA) enforcement action, and best practices to navigate and mitigate FDA enforcement.

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By Jennifer Diaz|2021-10-07T14:48:15-04:00August 10, 2021|COVID-19, Import, Import Alert, International Business, International Law, International Trade, Labeling, Medical Devices, PPE, Pre-compliance, Speaking, U.S. Food and Drug Administration (FDA)|Comments Off

FDA ISSUES ITS FIRST FSVP WARNING LETTER

The Food Safety Modernization Act (“FSMA”) is in full force and the U.S. Food and Drug Association (FDA) is now enforcing its Foreign Supplier Verification Program (FSVP) regulation. This blog discusses FDA’s first FSVP Warning Letter and illustrates what NOT to do when FDA starts asking questions about your products. The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food imported into the United States has been produced in a manner that meets applicable U.S. food safety standards.

In the case of the U.S. importer who received the FSVP Warning Letter, their FDA issues started in the beginning of 2019 when a salmonella outbreak ravished multiple states and was traced back to the importer’s tahini product.

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By Jennifer Diaz|2021-10-28T15:35:34-04:00September 4, 2019|U.S. Food and Drug Administration (FDA)|1 Comment

THE FDA IS FLEXING ITS ENFORCEMENT MUSCLES

At today's Food and Drug Law Institute's annual conference in Washington, D.C., the U.S. Food and Drug Administration's Commissioner Margaret Hamburg, M.D. said that one of her priorities is responding to the globalization of the food supply, and the increase in misbranded and adulterated food products imported into the United States

By Jennifer Diaz|2010-04-22T09:05:24-04:00April 22, 2010|Food, Import, U.S. Food and Drug Administration (FDA)|Comments Off

FDA Finally Getting Tough on False Food Claims

The U.S. Food and Drug Administration recently issued several warning letters to prominent food and drink companies regarding false claims on their food and drink products, including those marketed to children. Some food products brazenly claim to increase a person's immune system, reduce the chance or getting a cold, or even cure cancer. Are they really believable?

By Jennifer Diaz|2010-03-09T10:31:36-05:00March 9, 2010|Food|Comments Off