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For Wholesale Distributors, the FSMA 204 ruling means finding an optimum balance between high transaction velocity, where goods movement cannot stop, and your need ensure you have complete traceability data for compliance.  

Helping Wholesalers address FSMA 204

Having helped one of the largest Wholesale Distributors in the world successfully address FDA Traceability Compliance, the TagOne team has a unique take on Wholesaler compliance, one that has been vetted over the years time and again. 

With Wholesalers typically dealing in large volumes and high transaction velocity, we always say "Think Pragmatic Operations Discipline First" via the process of Exception Management.


How well you can identify and address exceptions quickly rather than getting every transaction right will decide your compliance programs success

This is a lesson learnt the hard way for a lot companies.

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Receiving KDEs


  • Traceability lot code for the food

  • Quantity and unit of measure of the food

  • Product description for the food

  • Location description for the immediate previous source (other than a transporter) for the food

  • Location description for where the food was received

  • Date you received the food

  • Location description for the traceability lot code source or the traceability lot code source reference

  • Reference document type and reference document number


Shipping KDEs


  • Traceability lot code for the food

  • Quantity and unit of measure of the food

  • Product description for the food

  • Location description for the immediate subsequent recipient (other than a transporter) of the food

  • Location description for the location from which you shipped the food

  • Date you shipped the food

How TagOne Helps
Wholesale Distributor's 
Address FSMA 204

  • TagOne will provide its Wholesaler customers multiple components of its TagOne Compliance Link solution kit that will ensure easy capture and sharing of FSMA 204 relevant KDEs across its suppliers and customers

  • TagOne Supplier Link will ensure your suppliers especially the small and medium sized ones are able to enter shipment data to share with you. This can be done in multiple ways like:

    • Web UI​

    • Mobile UI

    • Excel 

    • CSV

    • Mobile Scanning 

    • OCR (Optical Character Recognition)

  • TagOne's ASN Translation Service will automatically translate this information into an ASN that will be shared with you​

  • TagOne Integration Engine will help you connect directly with your bigger suppliers via our open API framework and receive their shipment data electronically either as EDI/AS2 or as an EPCIS message

  • TagOne Customer Link will ensure your customers (Retailers/Other) receive your ASNs automatically in their Inbox. They can additionally use advanced TagOne features like Mobile Scanning, OCR, an other features to easily capture Receiving, Transformation and Shipping (For e.g., Internal Transfers) CTEs and ensure 100% FSMA 204 compliance 

  • The TagOne Compliance Cockpit provides advanced Error Reporting to ensure Wholesalers can efficiently manage their FSMA compliance via thorough Exception Management. A few examples of the different reports below

    • TLC Mismatch

    • Quantity Mismatch

    • Missing ASN

    • Pending Receiving

    • Missing Date ​

    • Missing TLC Source

For Larger Wholesale Distributors
  • TagOne will integrate with your existing MES, ERP, Warehouse Management or Logistics systems to automate the capture of KDEs supporting the Receiving and Shipping CTEs

  • TagOne will be your Central Regulatory Repository & the Single Source of Truth for all things FDA

  • TagOne supports integration with leading-edge solutions

The TagOne Value

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Central Regulatory Repository

TagOne is your Single source of truth for all FDA-related traceability data and documents.

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Traceability Data Digitization

TagOne will enable you to Capture, Store, and Share relevant traceability data on an “as-needed” basis.

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Traceability Reports in Seconds

On a button-click, fetch the TagOne Traceability Map view or Table view report based on Item name/Lot#. This is all you will need in the case of an FDA inquiry.

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Traceability Consulting

TagOne is not only your tech traceability platform of choice but our traceability experts will help you navigate this traceability journey every step of the way.

TagOne FSMA 204 Offerings

From SaaS options to consulting and advisory, the TagOne team fully understands that comprehensive traceability is a journey and we will support you every step of the way.

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