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The Rising Tide of Produce Imports from Latin America Trends Challenges and Safety Measures for Importers
The United States now imports nearly 59% of its fresh fruit and 36% of its fresh vegetables from abroad. Most of that supply flows north from Mexico and Latin America. That dependency has been building for two decades, and the numbers tell a clear story about where food safety pressure is heading next. Two Decades of Growth In 2004, U.S. agricultural imports from Latin America were significant but manageable in scope. By 2024, the picture looked dramatically different. Mexico
Dan Simonsen
Jul 235 min read


What Is FSMA? A Practical Breakdown for Food Importers and Manufacturers
I spent years enforcing FSMA before most of the companies affected by it had finished reading the summary. So when people ask me what it actually means in practice, I try to give them a different kind of answer than they'd get from a lawyer or a trade association. The short version: FSMA changed who is responsible for food safety in the United States, and most companies still haven't fully absorbed that. The Pre-FSMA World Before 2011, FDA's posture toward food safety was mos
Dan Simonsen
Jul 163 min read


What FDA is Looking For in a 483 Response
I spent years as an FDA Investigator drafting and issuing 483 Inspectional Observations to noncompliant firms. I read dozens of 483 responses as a Compliance Officer and noticed that companies across food, supplements, and cosmetics write bad 483 responses for the same reason: they do not know what the agency is actually looking for. The 15-day window is real When an investigator hands you a 483 at the close of an inspection, you have 15 business days to submit a written resp
Dan Simonsen
Jul 23 min read
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