Food traceability used to mean being able to do a mock recall once a year with enough time and enough people. The FDA’s Food Traceability Rule, known as FSMA 204, changes the standard: for foods on the Food Traceability List, companies must keep specific records at specific points in the supply chain and hand them to the FDA, sorted and electronic, within 24 hours when asked. That is very hard to do with paper and spreadsheets, which is why food traceability software is now on the shortlist for most food and beverage manufacturers. This guide explains what the rule asks for, what traceability software needs to do to meet it, and how to decide between a standalone traceability tool and traceability built into your ERP.
What FSMA 204 requires
The rule applies to companies that manufacture, process, pack or hold foods on the FDA’s Food Traceability List, which includes items such as leafy greens, fresh-cut fruits and vegetables, shell eggs, soft cheeses, finfish, crustaceans and mollusks, and foods that contain listed foods as an ingredient where the listed food stays in the same form. The original compliance date was January 20, 2026. The FDA has proposed moving it to July 20, 2028, and Congress has directed the agency not to enforce the rule before that date.
The core requirements are:
- Critical Tracking Events (CTEs). Records are required at defined points: harvesting, cooling, initial packing, first land-based receiving, shipping, receiving and transformation. For most manufacturers, receiving, transformation and shipping are the events that matter.
- Key Data Elements (KDEs). Each event has a defined set of data to capture, such as the traceability lot code, quantity and unit of measure, product description, location, dates, and the reference document for the transaction.
- Traceability lot codes. A lot code is assigned at initial packing, first land-based receiving or transformation. Shipping and other events must not create a new one, so the code that comes in is the code that goes out unless the product is transformed.
- A traceability plan. A written description of how records are kept, how listed foods are identified, how lot codes are assigned and who the point of contact is.
- The 24-hour sortable spreadsheet. During an outbreak, recall or other public health threat, the FDA can ask for an electronic, sortable spreadsheet of the relevant records within 24 hours.
There are full and partial exemptions, including for some smaller businesses, and the FDA provides a tool to check whether they apply.
Why spreadsheets struggle
Most food manufacturers can trace a lot today, given enough time. The problem is the 24 hours and the transformation step. When incoming lots of several ingredients are blended into a new finished lot, the link between inputs and outputs has to be recorded at the moment of production. If it is reconstructed afterward from batch sheets, the 24-hour window is gone before the search begins, and the records are only as accurate as the handwriting on the floor.
What food traceability software needs to do
Whatever product you choose, it should cover these capabilities:
- Lot capture at receiving. Supplier lot codes and your own traceability lot codes recorded against the receipt, with the KDEs the rule requires.
- Lot-to-lot genealogy through production. Every ingredient lot consumed linked to every finished lot produced, including partial lots, rework and co-products.
- Lot capture at shipping. Every lot shipped linked to the customer, ship-to location and shipping document.
- Forward and backward trace. From an incoming lot to every customer who received product made from it, and from a finished lot back to every supplier lot in it, in minutes.
- The sortable spreadsheet on demand. A report or export of CTEs and KDEs in a format you can deliver to the FDA without manual assembly.
- Hold and release. The ability to place a lot on hold so it cannot be picked or shipped while it is investigated.
- Expiration and shelf-life control. First-expired, first-out picking and visibility of lots approaching expiry.
- Mobile or scanner capture. Barcode scanning at receiving, production and shipping, because manual keying is where errors come from.
Standalone tool or traceability inside your ERP?
Standalone traceability platforms exist, and some are good at supplier collaboration and data exchange across the supply chain. The trade-off is that they sit beside the system where inventory, production and shipping are actually recorded. Every receipt, batch and shipment has to reach the traceability tool, either by integration or by double entry, and the trace is only as complete as that feed.
When traceability is built into the ERP, the lot is recorded on the same receipt, work order and shipment that update inventory and costing. There is no second system to keep in step, and the trace uses the same data finance and operations already rely on. For most food and beverage manufacturers, that makes the ERP the better system of record for traceability, with external tools used where supplier data exchange needs them.
How traceability works in NetSuite
NetSuite handles lot traceability natively. Lot-numbered items carry lot codes from receipt, through work orders and assembly builds, to item fulfillment. Expiration dates and inventory status support holds and first-expired, first-out picking, and lot and serial trace reporting follows a lot forward to customers or backward to suppliers. Our post on lot tracking in NetSuite covers the setup and how to run a mock recall, and the inventory and lot traceability page covers the module in more depth.
Food and beverage production usually needs more than standard assemblies: formulas that scale, batches with yield variation, catch weight and co-products. Consule’s ProShop adds formula-driven batch manufacturing to NetSuite, so lot genealogy is recorded where the batch is actually made, and FactoryBridge brings lot capture and quality checks to the shop floor.
Getting ready
- Check coverage. List the foods you handle that are on the Food Traceability List, or that contain listed foods, and check whether an exemption applies.
- Map your CTEs. For each listed food, identify where receiving, transformation and shipping happen and who records them.
- Close the gaps. Find every point where lot information is written on paper or keyed in later, and decide how it will be captured at the time.
- Write the traceability plan. Document lot code assignment, record keeping and the point of contact.
- Test the 24 hours. Run a mock trace from a supplier lot and from a finished lot, produce the spreadsheet, and time it.
Consule Solutions implements NetSuite for food and beverage manufacturers, with traceability designed into receiving, production and shipping from the start. If FSMA 204 is on your list, talk to us.
Frequently asked questions
What is food traceability software?
Food traceability software records lot information as ingredients are received, transformed into finished products and shipped, so a company can trace any lot forward to customers or backward to suppliers. Under FSMA 204 it also needs to produce the required records as an electronic, sortable spreadsheet within 24 hours of an FDA request.
When is the FSMA 204 compliance date?
The original compliance date was January 20, 2026. The FDA has proposed extending it to July 20, 2028, and Congress has directed the agency not to enforce the Food Traceability Rule before that date.
What are Critical Tracking Events and Key Data Elements?
Critical Tracking Events are the supply chain points where records are required: harvesting, cooling, initial packing, first land-based receiving, shipping, receiving and transformation. Key Data Elements are the specific data captured at each event, such as the traceability lot code, quantity, product description, location and dates.
Can an ERP handle FSMA 204 traceability?
Yes, if it records lot codes at receiving, links consumed and produced lots during production, records lots at shipping and can report the required data on demand. Traceability in the ERP avoids keeping a separate system in step with inventory and production.
Does NetSuite support lot traceability for food manufacturers?
Yes. NetSuite tracks lot-numbered items from receipt through production to shipment, supports expiration dates and inventory status for holds, and provides lot and serial trace reporting forward and backward. Formula and batch manufacturing needs are often covered by add-ons such as Consule’s ProShop.