What happens when a foreign manufacturer gets put on an FDA import alert? Or when a single undocumented ingredient turns a harmless dietary supplement into an unapproved drug? In this episode of Out of the Lab, host Nico sits down with Dan and Binh from Wynngate Consulting. Bringing decades of insider FDA experience from compliance enforcement to foreign facility inspections, they pull back the curtain on the operational realities of GXP manufacturing. We explore the massive

For almost 70 years, the food industry has run on an honor system. If a company decided an ingredient was Generally Recognized as Safe, or GRAS, it could put that ingredient in your food without ever telling FDA. No form. No notice. No "hey, just so you know." You determined it was safe, you wrote it down internally, and you shipped it. On August 10, 2026, FDA proposed ending that arrangement. The agency wants to make GRAS notification mandatory instead of voluntary, which so

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

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

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

In February, FDA published its Human Foods Program 2026 Priority Deliverables — roughly 25 items spanning chemical safety, nutrition, and microbiological food safety. Almost five months in, the honest answer is: some of it is moving, some of it isn't, and which is which doesn't always match the order FDA listed them in. Food Chemical Safety GRAS reform is likely the most polarizing deliverable, and it has been since its final rule was released 10 years ago. Right now, a compa

Most importers think the clock starts when their product hits the port. It doesn't. By the time a container is sitting on the dock, FDA has already decided how hard to look at it. I spent my first years at the agency inside the Office of Import Operations conducting Entry Review at both the LAX Airport and Port of Long Beach. I've seen hundreds of thousands of lines of products. If you want to avoid a detention, the work happens before arrival, not after the hold notice shows

My personal testimony For most of my career, I worked the other side of the table from the people reading this. I spent 17 years at FDA. Thirteen of them as a Consumer Safety Officer walking the floors of food, beverage, and supplement importers around the Los Angeles District, and the last few as a Compliance Officer at a GS-13 level inside the Office of Import Operations, Division of West Coast Imports. That division covers the LA/Long Beach port complex, which is the busie