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FSMA 204 Traceability for Small Food Brands

Small food brands should build FSMA 204 traceability in this order: assign traceability lot codes, capture the Key Data Elements for every critical tracking event, and link supplier records so an FDA request takes minutes instead of weeks.

The vocabulary that matters

  • Critical Tracking Events (CTEs): harvesting, cooling, packing, receiving, transforming, and shipping
  • Key Data Elements (KDEs): the data recorded at each CTE, including traceability lot codes, quantities, locations, and dates
  • Traceability plan: your documented procedure, required regardless of company size

Build order for a small brand

  1. Lot code scheme: unique, consistent, and applied at every CTE. This is the foundation
  2. Receiving and shipping records: the two events every brand controls directly
  3. Supplier links: who sent what lot, with their own traceability records
  4. Export ready records: the FDA can request records within 24 hours, in a sortable electronic format

What the FDA request looks like

The FDA identifies a food, a lot, or a facility, and you must supply the traceability records for that item. The test is whether your records reconstruct the path in minutes. Most small brands fail because lot codes stop at their own dock.

Frequently Asked Questions

Does FSMA 204 apply to small brands?

Yes. The rule covers all entities on the Food Traceability List, including small firms, although compliance dates are staggered by size.

What format do records need?

Electronic and sortable. A spreadsheet can work at small scale, but it must hold the complete KDEs per event.

Is a traceability plan mandatory?

Yes, it is a separate requirement, and it must describe your lot coding, recordkeeping, and procedures.

Build Your Traceability Records Free

Capture KDEs per critical tracking event, link supplier lots, and keep export ready records. No card required.

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Global Digital Trust & Compliance

Sustalium is the digital-first platform for managing complex business certificates and sustainability declarations across global supply chains.

Environment & ESG
  • Digital Product Passport (DPP)
  • Carbon & Water Footprint
  • Circularity & Reuse (ISO 14021)
  • De-Forestation Free
Product & Food Safety
  • FSMA 204 (FDA Traceability)
  • REACH & RoHS Compliance
  • PFAS-Free & VOC Declarations
  • Prop 65 & TSCA Title VI
Social & Ethical
  • ISO 26000 Responsibility
  • Modern Slavery Statements
  • UFLPA Forced Labor Traceability
  • Ethical Labor Declarations
Governance & Trade
  • Swiss Made & Origin Claims
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  • CE Marking & UKCA Conformity
  • Bill S-211 (Canada) Reporting
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