How ready is the food industry for FSMA 204? To answer that question, I joined Bill Bremer, Regulatory Affairs Advisor and board member of the Food Safety Professionals Group, and Joe Buckley, Director of Food Safety and Quality Assurance at Sysco, for a Food Safety Magazine webinar on building a traceability-ready operation under FSMA 204. Many thanks to moderator Adrienne Blume for facilitating the discussion and keeping the great questions rolling in.
As people who spend our days working in the world of recalls, audits, and supplier onboarding, our goal was to share our real-world experience with how FSMA 204 will really impact food manufacturers and suppliers.
One number from the FDA’s own tabletop exercise framed the whole hour: only 27% of participants could produce a complete traceability lot code (TLC) source across every critical tracking event (CTE) they were asked about. Most of the room could hit the 24-hour response window, but far fewer could prove the data behind it was clean.
That gap, between responding quickly and responding correctly, is the real story of where the industry stands with about two years left on the clock.
Below, I’ll share five learnings about the gap that the food manufacturing industry needs to bridge to get to FSMA 204 readiness.
Speed isn’t readiness
In our opening poll, about 25% of attendees said they’re still reviewing data and system gaps, and another 20% are still assessing scope; all of this ’s encouraging progress. Bill Bremer, however, put it plainly: the FSMA 204 extension to July 2028 bought time, but not room to coast. Harmonizing lot codes, TLCs, and KDEs across systems that were never built to talk to each other takes practice, and that practice has to start now and keep running straight through implementation.
Joe Buckley made the sharper point: his team can already answer a recall request in 24 hours. What worries him, however, is that speed can mask a shakier foundation. You can’t find the gaps in your food traceability plan until you actually run it, in the same way a game plan only proves itself once you’re on the field.
Joe also raised a point I don’t think gets said enough on FSMA 204-themed webinars: this challenge isn’t an FSQA-only problem. Building a working CTE register pulls in operations, sales, legal, and merchandising, because each team touches a handoff where a traceability lot code can get dropped. If a company treats this issue as a compliance-team project, it stays a compliance-team project, and the gaps stay open.
You’re only as compliant as your suppliers
The above line was Joe’s, and it’s the one I’d want every FSQA director to sit with. A distributor moving product from thousands of suppliers to thousands of customers can build a perfect internal system and still fail a trace if a supplier’s lot code never made it into the supply chain.
The fix isn’t asking every supplier to do things 100 different ways. The answer involves converging on common data standards, GS1 identifiers, GDSN attributes, EDI 856 advance ship notices, and SSCC pallet labels, so a small produce supplier and a national account can hand off the same KDEs the same way.
We’re seeing this firsthand in the Supplier Compliance work Nulogy does with distributors and co-manufacturers: the organizations going in with clean supplier master data are the ones who have smoother progress implementing FSMA 204 requirements. The accounts still chasing certificates and contacts are the ones running mock recalls that take days instead of hours.
The technology gap is a data gap
When moderator Adrienne Blume asked whether the industry’s biggest shortfall was technology, data, ownership, or process, my answer was that it’s rarely just a single factor. I emphasized that the data problem hides inside the technology problem more often than people expect: a dropped leading zero on a UPC or a mismatched date format looks trivial, until an investigator is waiting on the other end of a trace that won’t resolve.
Most of the data already exists somewhere in a plant’s ERP, WMS, or QMS. The job isn’t simply ripping that out; it’s building a CTE register that pulls from existing lot codes and shipping records, validates them as they’re ingested, and surfaces the malformed ones before they become an audit finding.
That’s also why most of our poll respondents said they’re extending existing systems rather than building new ones, and why that’s the right instinct, provided the supplier compliance layer underneath is solid.
Test one product before the FDA does
Joe’s closing advice was the most practical thing said all hour: pick one high-risk product on the Food Traceability List and run it, on paper or in your system, from supplier lot through receiving, storage, picking, shipping, and customer delivery. See where the plan collides with your actual operation, not the one in the slide deck.
That’s also where corrective actions matter more than how most FSQA teams currently treat them. Bill’s warning was direct: an open corrective action, sitting untracked in an inbox instead of a system, is a vulnerability point in a recall. And a GFSI certificate, IFS, BRCGS, or otherwise, doesn’t cover you here. It complements FSMA 204, and isn’t meant to be a substitute for it.
Where this leaves FSQA teams
Two years feels like a long time until you count the number of trading partners you need to bring along with you. Nulogy’s software already helps run this kind of real-time food safety and quality oversight across hundreds of food manufacturing sites worldwide, and the pattern holds everywhere else we see it: the companies that treat harmonization as an ongoing discipline, not a project with an end date, are the ones who’ll answer the FDA’s question cleanly when it matters.
If you want help finding out where your own CTE register would break under a live request, my team would rather help you find that now, than watch you find it during an actual recall.
Get in touch with us today, or see firsthand how Nulogy’s software can help you bolster your FSMA 204 readiness.