Solution
Comply with FSMA 204 without the deadline pressure
The FDA's new Food Safety Modernization Act requires traceability records for high-risk foods. The deadline was extended to July 20, 2028 — but that's not a pause, it's a window to digitize properly.
What the regulation requires
The three pillars: CTE, KDE and TLC
Mandatory records for high-risk foods
FSMA 204 applies to the Food Traceability List (FTL): fruits, vegetables, soft cheeses, seafood and other products where contamination has greater impact on public health.KDEs — Key Data Elements
Data tied to each lot: date, location, quantity, supplier, type of processing. These are the mandatory fields to capture.
CTEs — Critical Tracking Events
Events that must be recorded: harvest, receiving, transformation, shipping. Each event connects KDEs to a moment in the lot's life.
TLCs — Traceability Lot Codes
Unique codes per lot that allow tracking the product across the chain, down to point of sale.
How Darwin helps
From capture to report, all digital
We cover every step of the data cycle required by FSMA 204 with integrated tools.
KDE capture at origin
With Captia, KDEs are logged in the field or plant from any mobile — even offline.
FDA-ready CTE structure
Tracium organizes events in a CTE format compatible with FDA audit requirements.
Unique on-chain TLCs
Each lot gets a verifiable unique code, with immutable blockchain recording for integrity.
Recall in under 24 hours
When an incident happens, locate and communicate affected lots in minutes, not days.
Automatic reports
Generation of FSMA 204 audit-ready reports, with end-to-end traceability.
Share with retailers
Integration with Walmart, Amazon, Whole Foods and other retailers that require FSMA 204 compliance.
Timeline
The plan to July 2028
Today → 6 months: Discovery + Pilot
We map your chain, identify CTEs and run a scoped pilot with a subset of operations.
6 → 18 months: Scale-up and consolidation
Full rollout, ERP and retailer integrations, user training.
18 → 30 months: Hardening and audits
Fine-tuning on real data, first recall simulations, audits with key retailers.
July 2028: Compliance confirmed
Digitized operation, automatic reports, recall response in <24h. Not starting late, arriving battle-tested.
FAQs
Frequently asked questions about FSMA 204
Who does FSMA 204 apply to?
Companies that produce, pack or store high-risk foods on the FDA's Food Traceability List (FTL). Includes fruits, vegetables, soft cheeses, seafood and other products.
What happens if I don't comply by July 2028?
The FDA can impose sanctions and, more importantly, major retailers (Walmart, Amazon, Whole Foods) will reject non-compliant products well before the official date.
Do I need to replace my ERP?
No. Darwin integrates with your existing ERP via APIs. We capture data that's missing (typically field data) and structure the rest for compliance.
How long does implementation take?
Pilot: 4-8 weeks. Full go-live: 3-6 months depending on the size and complexity of the operation.
Does it work for rural operations with poor connectivity?
Yes. Captia has offline-first capture with automatic sync — designed for the Latin American production context.
Start digitizing before it's too late
Companies that reach 2028 with proven systems will have an advantage over those starting with patched solutions. Let's talk about your operation.