Behind on FSMA 204? Get Compliant in 60 Days, Without Ripping Out Your Systems.

FSMA 204 (formally 21 CFR Part 1 Subpart S, the FDA's Food Traceability Rule) requires additional recordkeeping for anyone who manufactures, processes, packs, or holds items on the FDA Food Traceability List (FTL). It applies to a much wider set of businesses than most people realize: regional grocery chains, wholesalers, specialty processors, and foodservice distributors handling leafy greens, fresh-cut fruit, seafood, cheese, nut butters, or shell eggs are nearly always covered. If you touch an FTL item at any point between farm and retailer, the rule applies to you. Compliance is not optional based on size.

Technically, covered firms needed their traceability records in place by January 20, 2026. That said, the FDA has publicly signaled a remediation-first enforcement posture in the early months, and most enforcement pressure in 2026 is coming from retailers (Kroger, Albertsons, Whole Foods) demanding scorecard responses, not from FDA 483 warning letters. If you missed the deadline, you are not alone and you are not automatically in violation. You are in the window where you can still get compliant before a documented audit finding or retailer exit. TraceReady's 60-day program is designed for this gap.

No. This is the single most common misconception. ReposiTrak is a data-exchange and supplier-document layer that Kroger mandates for onboarded suppliers. It passes data between parties; it does not generate the KDEs and CTEs that FSMA 204 requires on your side. Most brands and distributors using ReposiTrak still fail their own internal KDE capture (lot linkage, receiving CTE, transformation CTE, shipping CTE) because that data has to originate from their ERP, WMS, or production system, not from ReposiTrak. Having a ReposiTrak seat and being FSMA 204 compliant are two different problems, and we routinely find customers who have paid for the first assuming it solved the second.

Because we don't run a supplier portal. We run a 30-day outreach playbook. Most supplier traceability projects die because the buyer sends a generic email, links to a portal the supplier has never logged into, and waits. TraceReady uses a scripted outreach sequence (initial ask, technical clarification, escalation to supplier leadership, contract-leverage escalation), standard data-agreement templates, and a weekly stand-up where we review every supplier's status with you and personally escalate the stalled ones. Our internal target for Tier-1 suppliers on a 30-day track is >70% data-flow activation, versus the industry's <20% on passive portal rollouts.

Typical first-year engagement is about $22,000 all-in. Onboarding is $5,000–$10,000 one-time (scoped to the number of FTL products, facilities, and suppliers involved). The ongoing program subscription runs $1,500–$3,500 per month and includes your compliance lead, weekly working sessions, supplier outreach management, SOP updates, and audit-defense support. We don't charge per-seat, per-SKU, or per-lot, and there's no separate implementation fee after onboarding.