Manufacturer Guide to Product Recalls

The impact of a recall on your business can be minimized by having an efficient, organized, and expedited response. In cooperation with the Georgia Department of Agriculture (GDA), U.S. Food and Drug Administration (FDA) and/or U.S. Department of Agriculture Food Safety Inspection Service (USDA-FSIS), you will be able to work through the recall process.

This document is intended to provide general guidance on executing and recovering from a recall. Several steps may take place concurrently.

Please note: this guide is for manufacturers.  See the Retailer Guide to Product Recalls.

Important Contacts

Within the First 24 Hours

  • If a finished product/ingredient sample has tested positive (even if the product is still in your control) contact the GDA at (404) 657-4801 or send details to positiveresults@agr.georgia.gov.
  • Complete a Reportable Food Registry (RFR) using your facility’s food registry number online at https://www.safetyreporting.hhs.gov/SRP2/en/Home.aspx?sid=986e9562-066f-4f40-ae81- 05d8ccf00b37.
  • The RFR Center answers questions about Reportable Food Registry policies, procedures and interpretations. Submit questions to: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/ContactCFSAN/.
  • The SRP Service Desk for technical and computer-related questions about the Reportable Food Registry electronic portal. Email questions to: SRPSupport@fda.hhs.gov.
  • Make direct contact with the GDA, FDA and, if needed, the USDA-FSIS Atlanta District. Be prepared to provide information about the status of your product, nature of the recall, root cause behind the issue (if known), any consumer complaints, distribution information, etc.
  • The Recall Coordinator with FDA and/or GDA will support your recall operations and provide assistance in drafting a public notification about the recall. Things to include: Product descriptions, distribution, sizes, lot codes, types of packaging, etc.
  • The GDA and FDA will determine primary jurisdiction at your facility and may plan to conduct an on-site recall investigation.

The Recall Investigation

Prompt identification of affected product(s) and source(s) of contamination means a reduced scope of the recall and time to product withdraw. Helping your regulatory officials in turn helps ensure an efficient and effective recall.

Help the federal and state inspectors obtain the following:

  • Scope of the recall, which ensures the recall is not too broad (leading to additional losses) or too narrow (requiring subsequent or expanded recalls).
  • Up-to-date inventory for finished product, in-process material and/or raw materials present in your facility.
  • Up-to-date distribution, including a list of customers who received the product (could be sales records, shipping manifests, invoices, or other business documents).

Provide assistance and education to GDA & FDA about the meaning of product or lot codes used in your facility. The more rapidly specific products or lots affected are catalogued, the more rapidly the recall can be concluded.

Public Notification

Your public notification campaign will be an integral part of the product correction/withdraw. Prompt, forthcoming communication with the public can protect your business and hasten the recovery process.

  • Work with regulatory Recall Coordinator(s) to draft a recall press release notifying the public.
  • Include as much information as possible about:
    • Product name
    • Packaging description, size, UPC and/or lot code information
    • The reason behind the recall, including the contaminant of concern
    • Areas of distribution
    • Disposal instructions and availability for refunds
  • While GDA, FDA and/or USDA may issue their own press release, every opportunity will be given to allow the firm to release the information first.

Restoration and Recovery

Once the recall is initiated, begin planning your restoration, recovery, and strategy to prevent future occurrences. The GDA will provide support for your restoration and recovery process. FDA and/or USDA can also be available during this phase and throughout the recall process.

Questions?