FSMA 204 compliance checklist, step by step

To comply with FSMA 204, confirm the rule covers your foods, list the critical tracking events you perform, record the required key data elements for each lot, assign traceability lot codes where required, write a traceability plan, and be able to hand FDA your records within 24 hours. This FSMA 204 compliance checklist covers each step and its rule section.

The original compliance date was January 20, 2026. FDA has proposed moving it to July 20, 2028 (not yet final), and Congress’s FY2026 appropriations law directed FDA not to enforce the rule before that date, which FDA says it intends to follow. Check FDA’s Food Traceability Rule page for the current date, or read where the date stands. The steps below do not depend on it.

How do you use this checklist?

Work through the stages in order, once per product and per location. Each item names the section of 21 CFR Part 1, Subpart S it comes from, sections 1.1300 through 1.1465. FDA’s rule page has a Getting Started section that follows the same order.

Stage 1: Does the rule cover you?

List every product you make, pack, hold or sell, by location. Rule: 1.1300 applies the subpart to people who manufacture, process, pack or hold foods on the Food Traceability List.
Match each product to FDA’s Food Traceability List. A food that contains a listed food as an ingredient counts if the ingredient stays in its listed form. Rule: 1.1310, definition of Food Traceability List. See which foods are on the list.
Check every exemption and partial exemption for each product and location, and write down the numbers behind any size test. Rule: 1.1305. See FSMA 204 exemptions, or try FDA’s exemptions tool.
Record the answer for each product: list category or “none”, the reason, and the date. Rule: 1.1315(a)(2), your plan must describe how you identify listed foods.

Stage 2: Which critical tracking events do you perform?

Mark which events you perform for each covered product: harvesting and cooling before initial packing (1.1325), initial packing of a raw agricultural commodity (1.1330), first land-based receiving of seafood from a fishing vessel (1.1335), shipping (1.1340), receiving (1.1345) and transformation (1.1350). Rule: 1.1325 through 1.1350.
Note the carve-outs that apply to you. Shipping and receiving records are not required for a raw agricultural commodity before it is initially packed (1.1340(c), 1.1345(c)). Retailers and restaurants keep no transformation records for food they do not ship (1.1350(c)).
Repeat for each location. A distributor often has only receiving and shipping. A fresh-cut processor adds transformation.

Stage 3: Which data must you record?

Compare each event’s key data elements with what your invoices, bills of lading and production sheets already carry. Rule: 1.1325 through 1.1350. The key data elements guide lists them event by event.
Check every record for the basics: product description, quantity and unit of measure, date, location descriptions, and reference document type and number. Rule: each event section, with terms defined in 1.1310.
Link every key data element to its traceability lot, for example by printing the lot code on the document or keeping it in the same spreadsheet row. Rule: 1.1330 through 1.1350.
Set up what you must pass on. Shippers give the next recipient the shipping data (1.1340(b)). Harvesters and coolers give specified data to the initial packer (1.1325(a)(2), (b)(2)).
Decide which existing records you will reuse. You do not need to duplicate records you already keep, and the data can live in more than one set of records. Rule: 1.1455(f), (g).

Stage 4: Are your lot codes sorted out?

Identify when you must assign a traceability lot code: initial packing of a raw agricultural commodity, first land-based receiving from a fishing vessel, and transformation. Rule: 1.1320(a).
Do not create a new code for other activities, such as shipping. Rule: 1.1320(b).
Pick a code format and a lot size. The rule prescribes neither, so describe your choice in your plan. Rule: 1.1315(a)(3). See how to assign lot codes.
Carry the lot code source, either a location description or a source reference, with the code on shipping and receiving records. Rule: 1.1340(a)(7), 1.1345(a)(7).
Plan for suppliers that send no code. If the supplier is not covered by the rule, you assign a code at receiving, unless you are a retailer or restaurant. Rule: 1.1345(b)(1).

Stage 5: Have you written your traceability plan?

Your plan is a written document with set parts. Check that yours has each one. Rule: 1.1315.

How you keep records, including their format and location. (a)(1)
How you identify the listed foods you handle. (a)(2)
How you assign traceability lot codes, if applicable. (a)(3)
A point of contact: someone familiar with your traceability procedures, with a name or job title and a phone number. (a)(4), 1.1310
A farm map, if you grow or raise a listed food other than eggs. (a)(5)
A habit of updating the plan when your practices change, and keeping the previous version for 2 years after the update. (b)

Stage 6: Can you produce records within 24 hours?

Keep original records or true copies, such as scans or photos. Records must be legible and stored to prevent deterioration or loss. Rule: 1.1455(a).
Be able to give FDA all required records within 24 hours of a request, or within a reasonable time FDA agrees to, along with what is needed to understand them, such as code lists and glossaries. Rule: 1.1455(c)(1).
If another business keeps your records, or they are stored offsite, confirm they can be retrieved onsite within 24 hours. Rule: 1.1455(b), (c)(2).
Build the electronic sortable spreadsheet before you need it. In an outbreak, recall or other public health threat, FDA can ask for it for specified foods and date ranges or lot codes. Some smaller businesses may send another form. Rule: 1.1455(c)(3). See the 24-hour spreadsheet guide.
Keep records for 2 years from the date you created or obtained them. Rule: 1.1455(d).
Be ready to supply an English translation within a reasonable time if any records are in another language. Rule: 1.1455(c)(4).

Stage 7: Are your suppliers and customers lined up?

Tell suppliers what you need at receiving: the lot code, the lot code source, the quantity and the product description. Covered shippers must give you the shipping data. Rule: 1.1340(b).
Ask customers what they expect. Buyers may want more than the rule requires. See why retailers want traceability data.
If you rely on a kill step, or a change that takes the food off the list, applied by a later business, get the written agreement. It needs an effective date, printed names, signatures and the substance of the agreement. Both sides keep it, and it is renewed at least every 3 years. Rule: 1.1305(d)(6). The rule asks for written agreements only for specific exemptions like this one, not for supply chains in general.

Stage 8: Is your team trained?

The rule has no training requirement of its own, and Subpart S does not mention training. In FDA’s 2026 tabletop exercises, the most common gaps were lot codes and lot code sources that were missing, inconsistent or not captured together, which is a procedure problem before it is a software one. Treat these items as good practice.

Train receiving, packing, production and shipping staff on which fields to capture and why.
Write a one-page procedure for each event you perform.
Spot check a sample of records on a schedule you set.

Stage 9: Have you run a mock trace?

The rule does not require a drill either, but it is the quickest way to find where your records break.

Pick one lot, find every record for it, and time the exercise. The mock recall guide shows how.
Fix every gap you hit: each guess, inbox search and missing lot code.
Repeat after big changes, such as a new supplier, product or record system.

Frequently asked questions

Does FDA publish an official FSMA 204 checklist?

FDA’s rule page has a Getting Started section with the same questions in short form, plus an exemptions tool and a spreadsheet template. FDA also published a Small Entity Compliance Guide in 2023.

How long do I keep FSMA 204 records?

Generally 2 years from the date you created or obtained them (1.1455(d)). Some partial exemptions set their own period, such as 180 days for a retailer’s record of a direct farm purchase (1.1305(j)(2)).

Do I need special software?

No. The rule allows paper or electronic records, as long as they are legible and stored to prevent loss (1.1455(a)). The catch is the sortable spreadsheet FDA can request in an outbreak or recall, which is hard to build from paper on short notice, unless you fall under the size thresholds in 1.1455(c)(3)(iii).

What applies if I only receive and ship cases?

You keep receiving and shipping records for listed foods, and you pass on the lot code you were given rather than making a new one. You still need a traceability plan, and you still need to check exemptions. The plain-English guide covers the basics.

Where Lotcrumb fits

Lotcrumb is being built to turn this checklist into a working record: tag each product with its list category, pull key data elements from the documents you already handle, and produce the traceability plan and sortable spreadsheet on demand. Join the waitlist for early access.

This guide is general information, not regulatory advice. The rule has exceptions for specific businesses and foods, so confirm your obligations with FDA guidance or a food safety professional.