The U.S. Food and Drug Administration (FDA) recently finalized a guidance document outlining how companies and stakeholders should become “recall ready” to minimize buyers’ and users’ exposure to potential health risks.The Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C includes recommended preventative procedures that makers and distributors of regulated products should implement, including training, planning, and record-keeping to reduce the chance of a product recall.

“It is critical that all companies in the supply chain are ‘recall ready’ to ensure appropriate actions are taken swiftly across the distribution channels to best protect public health and the integrity of the supply chain.,” Associate Commissioner of Regulatory Affairs Judith McMeekin noted. “We will continue to work with companies to improve their recall procedures and minimize Americans’ exposure to potentially harmful products.”

The FDA’s recommendations

The report specifies several important steps companies should take to prepare for recalls:

• Companies should maintain adequate product-coding systems and maintain thorough distribution records in order to facilitate accurate identification and separation of specific lots of potentially harmful products.
• Manufacturers are urged to use electronic communication to quickly identify and alert suppliers, retailers, and the public of recalled products so they are made aware of the risk as quickly as possible.
• Rather than waiting for the results of an investigation, the FDA warns against stalling and urges companies to act quickly to initiate voluntary recalls as soon as they learn of a potential problem with their product.
• Companies are strongly encouraged to have appropriate training programs in place to ensure employees are ready to perform recalls efficiently. The FDA calls for training on “a regular basis so they have a thorough understanding” of the process. “A firm that anticipates complex recalls may want to consider additional preparatory steps, such as mock recalls, to verify the firm’s recall readiness. Mock recalls familiarize personnel with the recall process and may improve the effectiveness of the firm’s recall program.”

Since the passage of the Food Safety Modernization Act (FMSA) in 2011, the FDA has mandated that food companies create and maintain an adequate recall plan. But its recommendations of mock recalls to test those plans sends an important signal to companies that they need to strongly consider employing outside experts to assist in preparing for increasingly complex and costly recalls.

Under FSMA, the FDA has the authority to mandate recalls of certain products, such as biological products, controlled substances, medical devices, and foods. Finalization of this guidance on initiating voluntary recalls is the FDA’s latest action to improve the speed at which violative products are removed from the market without such forceful action. The agency wants to help companies with their procedures and encourage stakeholders to take matters into their own hands.

It is important to have a recall plan and mainstream system set up in order to make voluntary recalls a smooth process. We urge companies to review their current protocols and stay up to date with FDA regulations to avoid a mandatory recall in the future.

Trusted by the world’s leading brands, Sedgwick has managed more than 5,000 of the most time-critical and sensitive product recalls in 60+ countries and 20+ languages, over 25 years. To find out more about our experience with recall planning, simulations, and preparation, visit our website here.