Preparing to be “recall ready”

In March 2022, the FDA finalised guidance, “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff,” to help companies prepare to quickly and effectively remove violative products from the market. The guidance applies to voluntary recalls of products within the FDA’s jurisdiction. The guidance also discusses “how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws administered by FDA.”

Commenting on the FDA’s press release of March 3, Associate Commissioner of Regulatory Affairs Judith McMeekin, Pharm. D stated, “Voluntary recalls continue to be the fastest, most effective way for a company to correct or remove violative and potentially harmful products from the market to help keep consumers safe.” She continued, “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. We will continue to work with companies to improve their recall procedures and minimise Americans’ exposure to potentially harmful products.”

When public health is at risk, the guidance recommends initiating a recall prior to completing an investigation into the cause of the problem and also discusses preparations, recall initiation procedures and timely recall communications. The FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, the guidance describes the agency’s current thinking on the topic and should be viewed only as recommendations unless specific statutory or regulatory requirements are cited.

History has shown us time and time again that companies that are not adequately prepared to conduct a recall suffer real consequences. These recalls have resulted in harm to or even the death of consumers, damage to brand integrity through loss of consumer confidence, erosion of company reputation, decline in stock value and financial bottom line, and even bankruptcy. With the average US recall costing about USD 10 million and about 5% of US businesses realising recall costs of over USD 100 million, not including loses attributable to brand damage or lost sales (Source: “Recall Execution Effectiveness: Collaborative Approaches to Improving Consumer Safety and Confidence, Deloitte Development LLC in association with the Grocery Manufacturers Association,” May 2010, p 9), companies should make sure they are recall ready and properly prepared to avoid these ramifications.

It is critical for firms in a product distribution chain to be recall ready. The FDA recommends that a firm make the following preparations as appropriate and applicable to its operations in advance of when a recall may be required:

General preparations

For the timely initiation of a voluntary recall, it is essential that general preparations are in place before a recall is necessary. These include but are not limited to:

Procedures for initiating and enacting a recall

Companies should have prepared a written recall plan before a recall is required. Whether in paper or electronic format, a prepared, maintained and documented plan that specifies actions for initiating a recall and carrying out actions required for a successful recall should be readily available to all recall team members. These procedures should be considered part of a company’s comprehensive written contingency plan in executing recall actions. Written recall plans and procedures should be used for training to ensure understanding of recall requirements and verify the effectiveness of the plan. Educating the team on the recall plan and procedures helps to minimise delays in actions because of uncertainty and ensures that the team works effectively through knowledge of the procedures.

A company’s written recall plan and procedures should assign responsibility and describe all actions necessary and appropriate to conduct a successful recall. These include but are not limited to:

Other ways to prepare

These are some other powerful ways to be prepared for a recall that should be included as part of the recall plan.

Benefits of being prepared

The benefits of having a prepared plan and team include an ability to navigate a successful recall that protects the public and protecting the company’s brands as well as the company’s ability to maintain business. Being prepared for a recall minimises business disruption and the ultimate costs of the recall. Most importantly, being prepared for a recall can minimise harm to consumers and may even save lives.