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Food and Drug Branch

Industry Assistance: Product Recall Plan

It is important to plan ahead. Your food processing company may need to recall a product at some point. The recall may result from consumer complaints or your company has identified a problem. To recall a product, your company needs to be able to identify the product involved and determine the distribution of that product.

In the event of a foodborne illness outbreak, it is important to have traceback and recall procedures in place. We know that trace-backs cannot prevent foodborne illness from occurring. But being able to review good records and quickly trace a food back to its source can limit the public health and economic impacts of an outbreak. Food processors should develop and implement systems to facilitate tracebacks and recalls in the event of a problem. Food processors should test their systems regularly by conducting unannounced mock recalls. Traceback typically begins with the retail source of the food product thought to cause illness or injury and works back to a processing facility. Information from a traceback can often be used to aid in prevention of future illness outbreaks. Recall procedures are developed and used by processors to withdraw product that is already in the marketplace. A processor should be able to track all products. Records such as the supplier identification, production and distribution records for a specific lot of product should be orderly, properly maintained and easily retrievable in less than one hour. It is good procedure to periodically test the firm’s ability to retrieve information from the records by conducting mock recalls. Lot coding packages by date code or other coding may facilitate recovery of the product, if a recall is needed. Production records and date codes help put the puzzle together to identify the source. What are the consequences of an outbreak that implicates a product? Without records, the whole product line is suspect. All of the production procedures are suspect. More questions are raised than can be answered. Is the problem limited to only one day, one week, or one month of production? Is the source of the problem incoming product or employee practices? Has dirty equipment contaminated the product? If a production facility has accurate records of effective cleaning and sanitation of equipment, has well-trained employees, and pays consistent attention to GMP, Prerequisite Programs and HACCP, the facility will greatly reduce the likelihood of it’s products causing a foodborne illness outbreak.

A comprehensive guidelines, policies, and procedures for recalls can be found in Title 21, Part 7 of the Code of Federal Regulations. Please click on document below.

IA PDF/Recall Plan.PDF

To view the FDA’s recall policies, click on the link: www.cfsan.fda.gov/~lrd/recall2.html

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