+FontánADVISORY · FSMA 204 · TRACEABILITY
FSMA 204 READINESS AUDIT · FIXED SCOPE

Don't lose access to the U.S. market.

Every year, 1 in 6 Americans gets sick from contaminated food (CDC) — and since August 1, 2025, Walmart and Sam's Club require traceability on food and beverages. ASN, labeling, or data errors turn into chargebacks and erode margin today, not in 2028.

Fixed-scope audit · US$4,999 · 10 business days
1 in 6
AMERICANS SICKENED BY FOOD / YEAR · CDC
Jul 20, 2028
FEDERAL DEADLINE · NOW LAW
Aug 1, 2025
WALMART REQUIREMENT LIVE
24 hours
RECORDS FOR FDA
WHAT THE RULE REQUIRES

Formal traceability plan

The rule requires documented traceability procedures — lot codes, KDEs, and CTEs defined before FDA asks.

Records within 24 hours

When FDA requests records, you must produce them fast — in a sortable electronic spreadsheet, within 24 hours.

2-year retention

Every traceability record must be kept for two years from the date it was created.

THE COST IS NO LONGER THEORETICAL

Three places where margin leaks

Traceability failures don't show up as fines first. They show up as rejected loads, relabeling, and deductions from your biggest customer.

01

ASN & data

The advance ship notice must match the order, the product, and the physical movement. Mismatches trigger receiving holds.

02

Lot code

Key Data Elements (KDEs) must stay attached to the lot through every Critical Tracking Event (CTE) — from origin to destination.

03

Packaging & labels

GS1-128, SSCC, and printed data must be legible, consistent, and scannable at receiving — or the load doesn't move.

Retail reach: large customers can require traceability beyond the products FDA includes in the Food Traceability List. Your contract sets the real bar.
READINESS AUDIT

Know what to fix before you invest

Fontán tests the full chain — data, operations, packaging, and the customer connection — and turns gaps into a prioritized path. Start with evidence, before committing capital to systems or integrations.

  • ✓
    ApplicabilityYour products, actors, exemptions, and customer requirements — what's actually in scope.
  • ✓
    CTE / KDE mapReceiving, transformation, lot creation, and shipping — every critical tracking event mapped.
  • ✓
    Retail readinessASN, GS1, labels, documentation, and integration points with your customer.
  • ✓
    Traceability testOne sample lot traced from origin to destination — and back.
  • ✓
    Executive roadmapCritical gaps, quick wins, owners, and implementation sequence.
WHAT YOU RECEIVE
  • 01Executive summary (PDF)
  • 02Scope & flow map
  • 03KDE matrix (editable Excel)
  • 04Readiness scorecard (0–4)
  • 05Prioritized gap log
  • 0630/60/90 roadmap
FIXED SCOPE
US$4,999
one-time · per operation
1 site 1 supplier 10 business days 100% remote

Protect margin and business continuity. A concrete assessment before larger commitments.

More than one site or supplier? That's a program — scoped and quoted separately.

Request the audit
WHO IT'S FOR

Built for food exporters to the U.S.

Especially teams selling into large U.S. retail chains, where the customer's requirements arrive before the federal deadline.

Fresh fruits & vegetables
Seafood
Processed foods
Suppliers to large retail chains
Want to see why this matters right now? 2026's outbreak and Import Alert cases, mapped — including the exact chain of events that put a LATAM exporter on automatic border detention.
START WITH EVIDENCE

One audit. A clear path. No guesswork.

Thirty minutes to see if the audit fits your operation.

Schedule a conversation
Nicolás Pombo · Founder npombo@fontangroup.com +1 (479) 250-8538