More than one year after the enactment of the Food Safety Modernization Act (FSMA), manufacturers and retailers are still learning to guide their way through the changes. Being that the Food and Drug Administration (FDA) can now enforce a recall on any covered food product, the need to have a recall plan in place is more important than ever.
Recall planning and execution require much more focus for manufacturers to minimize their business risk. Recalls are increasing in volume for several reasons – globalization, virtual manufacturing and fewer suppliers in the marketplace. In 2010, the FDA reported there were 3400 FDA recall events, which was the highest number in five years based on Inmar research. With FSMA, the FDA has expanded its reach and regulatory powers. More responsibilities have been placed on manufacturers and retailers. There are also new controls on imports, enhanced enforcement powers and new fees that can be levied.
Risk mitigation in a recall is the primary objective. Recalls demand significant pre-planning and ongoing support to ensure that companies facing potential recall situations can efficiently and effectively mitigate the risk to public safety and appropriately manage their overall corporate risk profile.
An appropriate recall plan for manufacturers will address traceability of product distribution, offer a solution to quickly contact customers, remove product from the market expediently, and maintain records to meet FDA requirements. Companies rarely have the internal resources to manage a recall event effectively as manufacturer’s recalls aren’t a normal course of business.
Inmar can develop and execute any recall plan using our network of call centers, notification services, product tracking, warehouse facilities, field force and destruction (hazardous and non-hazardous) capabilities. We offer consulting services to help identify gaps, while evaluating recall readiness. Inmar can also help ensure success by testing your recall plan, and implementing continuous improvement by staying up-to-date on industry changes and how they affect your company.