FDA Red List and Imported Smoked Salmon

A Canadian company contacted The Food Lawyers® reporting it had thousands of pounds of frozen smoked salmon embargoed at the U.S.-Canada border because an FDA spot-check found Listeria in some of the product. The company had also been put on the FDA "Red List" which meant all of its shipments would automatically be embargoed. The shipments were intended for a U.S. mass market retailer who would be the biggest customer in the Canadian company's history. The company was convinced its products were actually OK, but didn't know what to do.

First things First: We needed FDA to release the shipments stuck at the border. There is an FDA protocol for testing and releasing shipments that are stopped because the shipper is on the Red List. We worked with a certified laboratory to sample and test the embargoed products within applicable FDA guidelines and pushed FDA to expedite matters. Soon, the company's shipments started being cleared, one-at-a-time, and moving through customs. This saved the company from losing its big U.S. account.

Next, we had to get the company off the Red List. The Food Lawyers® works exclusively with three food scientists in situations like this. One is in California, another is in Dallas, and the third is on the east coast. We flew our east coast scientist to the Canadian processing plant, had him determine the source of the Listeria, and implement a cure. He did all of those things and produced a detailed report of his findings and remedial actions. We had eliminated the source of the problem.

With shipments moving through customs and the source of the problem cured, we petitioned FDA to remove our client from the Red List. Normally, this process involves an FDA inspection at the foreign processing plant. Our petition was extremely thorough and included our expert scientist's report and his C.V. which states he is a PhD microbiologist and retired Vice President for quality control of an international pharmaceutical company's infant formula business. FDA removed our client from the Red List without a plant inspection. The client continues to follow our expert scientist's processing advice and there have been zero problems since we took over the situation.

About 90% of the companies that get on the FDA Red List, abandon the U.S. market. Our client is very happy to be in the other 10%.


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