Myth: "Our ERP tracks lots, so we are ready for the FDA traceability rule." Reality: Lot tracking is the foundation. The rule asks for specific key data elements at specific critical tracking events, deliverable to the FDA within 24 hours of a request. Many ERPs record lots but not the full event data.
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TL:DR
Microsoft Dynamics 365 Business Central provides lot numbers, expiration dates, and forward and backward trace through item tracking, which supports recall readiness. FSMA 204 compliance additionally needs event-level data such as traceability lot codes, locations, and reference documents. Most food companies meet it with a Business Central configuration plus process controls and sometimes an ISV or add-on.
Key takeaways
FSMA 204 applies to businesses that make, process, pack, or hold foods on the FDA Food Traceability List.
Records must be available to the FDA within 24 hours of a request, which rules out manual reconstruction.
Business Central item tracking supports lot numbers, expiration dates, and tracing in both directions per Microsoft Learn.
The gaps usually sit in supplier data, receiving practices, and event-level records, not in lot numbers themselves.
Run a mock recall before you buy anything. It shows exactly which data you cannot produce.
Confirm the current compliance date with the FDA; it has moved.
What does the FDA traceability rule require?
The FDA Food Traceability Rule, issued under Section 204 of the FDA Food Safety Modernization Act, requires additional recordkeeping for foods on the Food Traceability List. Covered businesses record critical tracking events (such as shipping, receiving, and transformation) and the key data elements tied to each, including lot codes. They must provide records within 24 hours of request or a mutually agreed reasonable time (FDA).
Timing: The original compliance date was January 20, 2026. The FDA page describes a proposed 30-month extension to July 20, 2028, and notes that Congress directed the FDA not to enforce before that date. Verify the status on the FDA site before publication.
What does Business Central provide for lot traceability?
According to Microsoft Learn, item tracking in Business Central supports:
Lot, serial, and package numbers applied through item tracking codes
Expiration dates, with options to require entry and enforce strict posting
Warehouse tracking of numbers in warehouse activities
Traceability forward and backward through the supply chain, supporting quality assurance and recalls
For operations, that means you can answer "which customers received lot X?" and "which supplier lots went into batch Y?" from system data. See Dynamics Square's guides on lot expiration in Business Central and warehouse management.
Where are the gaps for FSMA 204?
| Requirement area | Business Central standard | Likely gap or action |
|---|---|---|
| Lot numbers and expiry | Yes, via item tracking codes | Enforce settings by item |
| Forward and backward trace | Yes, trace reports | Test with a mock recall |
| Traceability of lot code assignment and source records | Partial | Define rules; may need extension |
| Event data (location, date, reference documents) | Partly in documents and ledger entries | Map each CTE to a document and field |
| Supplier-provided KDEs | Not automatic | Supplier onboarding and EDI or portal |
| Sortable electronic record in 24 hours | Reports and Power BI possible | Build and test an export |
| Food Traceability List item flagging | Custom attribute likely | Add item category or attribute |
How to prepare in 90 days
Scope: List which products are on the Food Traceability List.
Map events: For each product, map receiving, transformation, and shipping to Business Central documents.
Mock recall: Pick a finished lot; trace upstream and downstream; time it.
Close gaps: Item tracking codes, mandatory expiry, receiving procedures, supplier data requests.
Build the 24-hour package: A saved report or Power BI view that exports the required fields.
Train: Receiving and shipping staff capture lot data at the dock.
Why Choose Dynamics Square USA for Lot Traceability Software?
Dynamics Square is a Microsoft Solutions Partner, founded in 2011, with 14+ years of experience delivering Microsoft Dynamics solutions. With 150+ Microsoft Certified Consultants and 500+ implementation projects completed across the USA, UK, and Canada, we help food manufacturers implement Microsoft Dynamics 365 Business Central to improve lot and batch traceability, track ingredients across production, monitor expiration dates, simplify product recalls, and strengthen quality control.
Our team delivers tailored ERP solutions that improve operational visibility, support food safety compliance, and help businesses build scalable manufacturing operations.
Book a demo with our experts to strengthen food safety and streamline lot traceability with Business Central.
Frequently Asked Questions
Lot traceability software records the lot or batch of every ingredient, work in progress, and finished good and links them across receiving, production, and shipping. It lets a company trace a problem lot to affected customers and suppliers quickly.
No ERP is compliant by itself. Business Central supplies the lot tracking and traceability foundation. Compliance depends on how you configure it, which events and data elements you capture, and whether you can produce records to the FDA within 24 hours.
Yes. Item tracking codes can calculate expiration dates, require their entry, and enforce strict expiration posting so the inbound date is respected at outbound, according to Microsoft Learn.
Businesses that manufacture, process, pack, or hold foods on the FDA Food Traceability List must comply, including certain foreign firms. Some exemptions apply, so check the FDA guidance for your products.
It depends on products, sites, integrations, and data quality. A focused item-tracking and reporting project differs greatly from a full ERP rollout. Scope it after a mock recall and process review.
