Managing Traceability and Recalls: Are You Prepared?

The FDA expects that a company will make every effort to remove unsafe food from the marketplace in the shortest time possible. The completion of a successful recall requires disciplined execution using reliable information on the raw materials, distribution and retail contacts. The time to test your recall/traceability capability is not during a real recall. Has your recall and traceability program proven to be effective? Does it include all the FDA regulatory inputs such as reporting requirements, regional contacts, use of guidance documents, recommended forms and reporting contacts with the FDA and/or state agencies? These are fundamental requirements that require a gap analysis to demonstrate that an organization is prepared, personnel are trained, responsibilities are defined and that alternates can complete required actions in the absence of key personnel. A thorough review of your recall/traceability program and your ability to remove product efficiently from the marketplace will provide internal and external confidence that regulatory requirements will be met, and that legal risk has been effectively reduced.

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