Introducing TrackAssure

What is FDA FSMA Section 204

The FDA Food Safety Modernization Act (FSMA) is a act that is intended to shift the focus from responding to foodborne illnesses with preventing them from happening.

Section 204 of this act is the Food Traceability Final Rule requiring businesses that manufacture, process, pack, or hold foods on the Food Traceability List (FTL) to maintain detailed records of Critical Tracking Events (CTEs) and Key Data Elements (KDEs). It aims to enable rapid identification of contaminated food, with compliance mandatory by July 20, 2028, and records must be provided to the FDA within 24 hours of a request.

Key Aspects of FSMA 204

Purpose: Enhance tracing of high-risk foods to speed up recalls and reduce foodborne illness.
Food Traceability List (FTL): Includes fresh leafy greens, nut butters, certain cheeses, shell eggs, fresh finfish/crustaceans, tropical tree fruits, and herbs.

Requirements: Companies must track specific events (harvesting, cooling, packing, shipping, receiving) and record Key Data Elements (KDEs) for each.

24-Hour Rule: Records must be retrievable and provided to the FDA within 24 hours of a request.

Timeline: While originally Jan 2026, the FDA has proposed extending the compliance date to July 20, 2028.

Who Is Affected?

The rule applies to any company (domestic or foreign) that produces, processes, packs, or holds foods on the FTL, including manufacturers, distributors, retailers, and restaurants.

Steps to Compliance

Identify FTL items: Determine if products or ingredients handled are on the Food Traceability List.
Map Supply Chain: Track Critical Tracking Events (CTEs) from farm to table.

Implement Data Systems: Establish digital or paper record-keeping for KDEs.

Practice Traceability: Ensure records are organized, accessible, and can be produced within 24 hours.

What is TrackAssure

TrackAssure is Ladle's answer to our clients, current and future, who are looking for a solution that will help them be in compliance of FDA FSMA Section 204.

The solution begins with the TrackAssure Mobile App, that allows users to carry out the following at their location:

• Record products Received, capturing information such as Supplier, GTIN, Manufacturer, Pack size, and Expiration date, as well as the ability to assign a unique LOT code for tracking.
• Record products Prepped, capturing information about the received product used, details of how the product was prepped (e.g., shredded, chopped, etc.), the date the product was prepped, and the shelf life. When you prep an item, you also have the ability to print a label that contains FSMA-compliant information to place on the prepped item packaging.
• Record products Transformed into dishes and packages, capturing information about products Received and products Prepped (i.e., Ingredients) that were used.

With this information, reports can be generated in the TrackAssure Web app:

• Received Products
• Prepped Products
• Transformed Products

Where do I begin?

If your organization is new to TrackAssure, you will work with your Ladle account executive to use the TrackAssure Web app to set up your organization's structure (groups, sub-groups, and locations), your organization and location users, and your suppliers and their products. All of this is detailed in in TrackAssure Web App.

Once your organization, locations, users, suppliers, and products are setup, you will use the TrackAssure Mobile App to capture information about received, prepped, and transformed products. All of this is detailed in TrackAssure Mobile App.

And finally, you will use the TrackAssure Web App to access FSMA Section 204-compliant reports about received, prepped, and transformed products. All of this is detailed in Product Tracking in TrackAssure.

What is GS1-128 and GTIN

A GS1-128 identifier is a high density barcode or QR code for identifying products. In the food service industry, a best-practice GS1-128 barcode includes the following:

• (01) A 14-digit Global Trade Identification Number (GTIN): The GTIN is used by a company to uniquely identify all its trade items. GS1 defines trade items as products or services that are priced, ordered, or invoiced at any point in the supply chain.
• (10) A 6-digit Product Date in YYMMDD format: The production date is the production or assembly date determined by the manufacturer. The date may refer to the trade item itself or items contained.
• (11) An 8-digit (typical) Batch/Lot Number: The batch/lot number associates an item with information that the manufacturer considers relevant for traceability of the trade item. The batch/lot number is a variable length number consisting of 1-20 characters. Examples of batch/lot numbers could be a production lot number, a shift number, a machine number, a time, or an internal production code, etc.

When you create product lists for suppliers in the TrackAssure Web App, each product includes the GTIN, if available. 

When you scan a barcode in the TrackAssure Mobile App, it will look at the format of the barcode and use the GTIN to locate the product in TrackAssure. The Product Date and Lot Number, if available, will also be captured.

When TrackAssure prints labels for prepped items, it uses a QR code instead of a barcode to present the FSMA-compliant identifying information.

Where can I learn more about traceability?

FDA Food Safety Modernization Act (FSMA)

Full Text of the Food Safety Modernization Act (FSMA)

SEC. 204. > ENHANCING TRACKING AND TRACING OF FOOD AND RECORDKEEPING.