FDA Issues Report on Global Supply Chain Oversight

By Mike Rozembajgier

Among the most significant outcomes of increased globalization is the international networking of supply chains and commercial trade. Global markets are increasingly interconnected and reliant on one other for the production and manufacture of a wide variety of goods, including food products, electronics, and children’s toys. In theory this can help reduce the cost of manufacturing a product, but it can also complicate the recall process. As previously outlined by ExpertINSIGHTS, with every new market comes a new set of challenges for the regulators bodies and companies responsible for managing the recall process.

With this in mind, the Food and Drug Administration (FDA) recently released a new report addressing the policy changes required for the agency to effectively meet its oversight responsibilities, including recall monitoring. The FDA report notes that “the safety of America’s food and medical products remains under serious threat,” and offers several examples of failed oversight, including contaminated blood-thinning drugs imported from China, counterfeit glucose monitoring strips and tainted pet food.

The FDA report, “Pathway to Global Product Safety and Quality,” outlines several “building blocks” for a new approach to food safety in the U.S. Among the recommendations are assembling global coalitions of regulators, developing data systems for the shared use of real-time information, and an effective allocation of intelligence gathering and risk analysis resources.

Just 10 years ago, six million shipments of FDA regulated goods were imported through the nation’s 300 ports of entry. Today, that number is closer to 24 million. According to the FDA, a typical U.S. manufacturing company relies on more than 35 different contract manufacturers around the world. New FDA strategies will address this changing landscape and anticipate the worldwide trends that are expected to continue in coming years.

Recall management for both companies and regulators has become increasingly demanding in light of this drastic shift. In a press release announcing the report, FDA Commissioner Margaret A Hamburg, M.D., explained that “there has been a perfect storm – more products, more manufacturers, more countries and more access. A dramatic change in strategy must be implemented.”

As the FDA report gains traction, more attention will most certainly be directed toward recall management processes and safety and compliance standards. With the FDA readying itself for action, all companies that rely on a global supply chain should be reevaluating their production networks and addressing any existing vulnerabilities. This includes ensuring that your business partners have recall plans in place that will support your recall management should the need arise.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

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