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:

  • Identifying appropriate personnel for the recall team including a recall team lead or coordinator and team members that have subject-matter expertise in multi-disciplinary functions as well as decision-making authority.
  • Providing adequate training of the team and extended team members on their roles and responsibilities on a regular basis. Preparatory steps may include workshops and simulation exercises focused on a recall scenario (not just a trace exercise) to verify the company and team’s readiness to handle the full spectrum of the recall and broader strategic implications. Recall simulation exercises provide a safe environment to test the effectiveness of the plan, process and team. Additionally, a review of the recall plan on an annual basis against best practice and regulatory metrics will ensure that the team has the most effective and up-to-date information and procedures.
  • Establishing a recall communications plan that addresses the communication needs for all internal and external stakeholders and regulatory bodies. Specific points of contact should be established ahead of time. Templates to address the types of communications needed for varying audiences should be drafted and approved ahead of time to issue recall communications promptly.
  • Identifying reporting requirements for distributed products. A company should know ahead of time whether its products are associated with any legal or regulatory requirements for reporting to the regulatory agencies.
  • Ensuring adequate product coding. Certain products must comply with specific product coding requirements. All other products should have sufficient coding for positive product and lot identification to facilitate an effective recall. It is also recommended to test systems to make sure that data needed can be obtained quickly and accurately.
  • Maintaining distribution records. Distribution records should be maintained by the recalling company to facilitate the location of products being recalled. These records should be retained for a period of time that exceeds the shelf life and expected use of the product and is at least the length of time specified in other applicable regulations regarding records retention.

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:

  • Ceasing production, distribution, shipment and sales of affected products.
  • Putting affected product within the company’s control on hold.
  • Developing a recall strategy that considers how a company will carry out recall actions.
  • Notifying direct accounts about the products being recalled and instructions on what to do with the product. Electronic communications are recommended for speed of delivery. If phone calls are made to notify accounts, calls should be followed up with a written notification confirming the information. Response instructions should also be provided to notified accounts.
  • Notifying the regulatory agency in a timely manner for recalls involving products that could result in illness, harm or death.
  • Notifying the public about products that could present a health hazard.

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.

  • Checklists are a great tool to make sure that all steps are assigned responsibility and carried out.
  • Include a glossary of terms so that everyone understands the same language and what the terms mean.
  • Links to regulatory guidance and regulations should also be provided to ensure compliance and serve as a quick reference to answer regulatory questions.
  • A matrix of 24/7 contact information for quick access to team members and other internal and external subject-matter experts (SMEs) who may be called upon during an investigation and recall should also be included.
  • A process diagram of the steps leading to a recall through the closing out of one is an invaluable graphic depiction that aids in tracking progress and identifying actions and next steps.
  • Communications templates to regulatory agencies and key stakeholders developed before a recall that can be modified at the time of the recall to include pertinent information. This will save time, confusion and ensure consistency in messaging to all who need to be notified.
  • Be prepared to set up a separate cost center to track all recall costs. This will make it less burdensome to separate costs associated with the recall versus those of normal business.
  • Designate a properly supplied meeting place for team members to convene and use as the command center of the recall. An alternate virtual or physical location should also be considered.

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.

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