FSMA 204 Readiness Checklist

What Is FSMA 204?

The Food Safety Modernization Act (FSMA) Section 204 is the FDA's lot traceability rule for high-risk foods. It requires you to track specific data points from farm to table for certain foods on the Food Traceability List (FTL).

Step 1: Determine If You're Subject to FSMA 204

Are You Manufacturing, Processing, Packing, or Holding FTL Foods?

The Food Traceability List includes:

• □ Fresh-cut fruits and vegetables (e.g., pre-cut lettuce, fruit mixes)
• □ Fresh herbs (e.g., basil, cilantro, parsley)
• □ Leafy greens (e.g., spinach, kale, arugula)
• □ Cucumbers, peppers, tomatoes, and sprouts
• □ Nut butters (e.g., peanut butter, almond butter)
• □ Shell eggs
• □ Fresh soft cheeses (e.g., queso fresco, brie, ricotta)
• □ Seafood (finfish, mollusks, crustaceans)
• □ Certain ready-to-eat deli salads containing FTL foods

✅ If YES: You must comply with FSMA 204.
❌ If NO: You're exempt, but good traceability practices still help with recalls and audits.

Step 2: Understand Key Data Elements (KDEs)

Critical Tracking Events & Required KDEs

1. Receiving (when you receive FTL ingredients)

Required KDEs:

• □ Traceability lot code (TLC) for the food received
• □ Quantity and unit of measure
• □ Product description
• □ Location from which the food was shipped
• □ Date of receipt
• □ Reference document type and number (e.g., invoice, PO)

2. Transformation (when you change an FTL food into a new FTL food)

Required KDEs:

• □ New TLC assigned to the transformed food
• □ TLCs of all FTL ingredients used
• □ Product description of the transformed food
• □ Quantity and unit of measure of the transformed food
• □ Date of transformation
• □ Location where transformation occurred

3. Shipping (when you ship FTL food to another entity)

Required KDEs:

• □ TLC of the food shipped
• □ Quantity and unit of measure
• □ Product description
• □ Location to which the food was shipped
• □ Date of shipment
• □ Reference document type and number

Step 3: Implement Traceability Lot Code (TLC) System

TLC Requirements:

• □ Must be unique (no duplicate TLCs for different batches)
• □ Must be readable and maintained throughout shelf life
• □ Can use existing lot codes, batch numbers, or serial numbers
• □ Must be recorded on your Traceability Plan

Example TLC Formats:

Step 4: Create a Traceability Plan

You must document your traceability procedures in a written plan. Your plan must include:

Traceability Plan Checklist:

• □ Description of FTL foods you handle — List all foods on the FTL that you receive, transform, or ship
• □ CTEs that apply to your operation — Identify which CTEs (receiving, transformation, shipping) you perform
• □ KDEs you track for each CTE — Document what data you collect and how
• □ How you assign TLCs — Describe your TLC format and assignment process
• □ How you maintain records — Explain where and how you store KDE data
• □ Procedures for providing records to FDA — Describe how you'll respond to FDA requests (within 24 hours)

Step 5: Set Up Record-Keeping Systems

Records You Must Keep:

• □ Receiving records — TLC, supplier, date, quantity for all FTL ingredients
• □ Transformation records — Input TLCs, output TLC, date, quantity, location
• □ Shipping records — TLC, customer, date, quantity for all FTL products
• □ Traceability Plan — Your documented procedures

Record Retention Requirements:

• □ Must be kept for 2 years
• □ Must be available to FDA within 24 hours of request
• □ Can be paper or electronic (electronic preferred for quick retrieval)
• □ Must be legible and prevent unauthorized changes

System Options:

Step 6: Train Your Team

Who Needs Training?

• □ Receiving staff (must record KDEs when FTL ingredients arrive)
• □ Production staff (must assign TLCs to transformed products)
• □ Shipping/warehouse staff (must record TLCs on outgoing shipments)
• □ QA/compliance staff (must audit traceability records)

Training Topics:

• □ What FTL foods your company handles
• □ How to identify and record TLCs
• □ Which KDEs to collect at each CTE
• □ How to use your record-keeping system
• □ What to do if an FDA request comes in

Step 7: Test Your Traceability

Mock Recall Exercise:

Before the January 2026 deadline, run a mock recall to test your system:

• □ Pick a random TLC from a finished product lot
• □ Trace backward to identify all ingredient TLCs and suppliers
• □ Trace forward to identify all customers who received that lot
• □ Time yourself — can you complete this in under 24 hours?
• □ Document gaps — note any missing data or slow retrieval points

Step 8: Prepare for FDA Requests

• □ All KDEs for the specified TLC
• □ One step back (supplier TLCs)
• □ One step forward (customer TLCs)
• □ Your Traceability Plan

FDA Request Response Checklist:

• □ Designate a traceability coordinator who can respond to FDA
• □ Create a response template with all required KDEs
• □ Test your system's ability to export records quickly
• □ Keep FDA contact info and your FDA Establishment Identifier (FEI) handy

Common Mistakes to Avoid

• ❌ Not checking if you're subject to FSMA 204 — Many founders assume they're exempt when they're not.
• ❌ Using non-unique TLCs — Reusing lot codes or using production dates alone won't work.
• ❌ Not linking ingredient TLCs to finished product TLCs — You must track transformation.
• ❌ Keeping records only on paper — You won't be able to retrieve them fast enough for FDA.
• ❌ Waiting until 2026 to implement — Start now to work out kinks before the deadline.

Quick Reference: Your FSMA 204 To-Do List

Need Help Implementing FSMA 204 Compliance?

If you're handling FTL foods and don't have a traceability system yet, book a discovery call. We'll tell you honestly whether custom software makes sense or if your current system just needs better processes.

Related resources:

• CPG Ops Gap Assessment — See if compliance is your highest-cost gap
• FSMA 204: What CPG founders actually need to know — Our full blog post on the rule