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FDA Urges Organizations to be Recall Ready

In March 2022, the US Food and Drug Administration (FDA) finalized their guidance to help various regulated industries initiated timely recalls of volatile products. The FDA is designating this as being "recall ready." The final guidance is an update to previously released guidance from April 2019, titled FDA Works to Improve Voluntary Recall Processes.

Recalls are either voluntary or required by the FDA. Voluntary recalls can be initiated by a company of their own accord, hence voluntary, or the FDA can notify and recommend that the company recall a specific product. The FDA has the authority to require recalls for certain regulated products under its guidance. This includes, but is not limited to controlled substances, biological products, human cells, tissues, and cellular and tissue-based products, medical devices and food stuffs.

Ensuring safety with dietary supplements

This specific guidance, Initiation of Voluntary Recalls under 21 CFR Part 7, Subpart C, discussed the steps companies should take to develop the necessary policies and procedures before a total mandatory recall is implemented. It is critical that organizations are recall ready not only to ensure the safety of all consumers and patients, but also to demonstrate to the FDA a willingness to cooperate and participate in voluntary recalls.

The FDA has stated that voluntary recalls are the fastest, most effective way to ensure the safety of consumers, as voluntary product recalls enable companies to correct or remove volatile and potentially harmful products from the market. In order to best protect the health of the public as well as supply chain integrity, it is the position of the FDA that all companies in the supply chain must be "recall ready." To ensure that companies are "recall ready," the FDA will work with directly with companies to improve recall procedures, ensuring appropriate actions are taken promptly across distribution channels, minimizing the exposure of consumers to potentially harmful products.

How product distribution chains can prepare for a voluntary recall

FDA outlines specific actions that should be taken in order to prepare organizations ahead of time and to achieve "recall ready" status:

  • 1. Assign appropriate personnel recall responsibilities.
  • 2. Train personnel to ensure they understand the policies and timeline for a voluntary recall.
  • 3. Establish a recall communication plan that clarifies necessary communication internally, with distributors, the FDA, and the public. The FDA suggests using electronic communications for the swiftest outreach.
  • 4. Identify any relevant reporting requirements such as what types of information the FDA will need and when they will need it. Certain problems with a distributed product may trigger a report to the Agency. Situations include product correction or removal such as removal of a medical device or recalling an infant formula. Other main examples include:

a. A report to the Reportable Food Registry.

b. An adverse event report for a dietary supplement.

c. A Field Alert Report for a distributed human or animal drug product.

d. A report of product deviation associated with the manufacturing of certain biologics.

e. A report in advance of a discontinuance or interruption in a firm or facility’s product of
a lifesaving drug that is likely to lead to a meaningful disruption in your own supply
or that drug.

  • 5. Set up and sustain adequate product coding systems to quickly identify and recall lots.
  • 6. Maintain thorough distribution logs as to quickly and accurately locate specific products and lots. Any organization who touches this product should maintain distribution as well.

More specifically, the FDA recommends documentation of all procedures for initiating a recall and performing actions related immediately to minimize any potential delays created by uncertainty. The written procedures and responsibilities assigned should include actions such as:

  • Cease distribution, shipment and/or sales of affected product(s);
  • Develop a recall strategy as set forth in 21 CFR 7.42, and
  • Notify direct accounts about the product being recalled, provide response instructions to notified accounts, and instructions for disposition of recalled product.

Establish a partnership with a trusted CRO/CDMO as part of your recall ready action plan

Element’s industry-leading scientific and regulatory experts are ready to partner with your organization to ensure you are "recall ready." From R&D to manufacturing to regulatory approval, we have the expertise and knowledge to support you. We make certain all the materials and products we test are safe, quality, compliant, and fit for purpose.

Element strives to provide absolute certainty by delivering accurate and reliable results for our clients testing needs, from small start-up ventures to large, established manufacturers. If you would like to connect with one of our experts or have questions about our experience with regulatory agencies or becoming "recall ready," contact us today.

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Jihye Jang-Lee, Ph.D., Pharmaceutical Director

Jihye Jang-Lee has nearly a decade of experience in lab operations and leadership in the biopharmaceutical and CDMO industries, with extensive expertise in quality assurance and quality control. With deep experience in small and large molecule methods and analysis, her leadership and expertise are instrumental in the growth of Life Sciences service offerings and teams. Dr. Jang-Lee’s unwavering client-centric approach ensures customers receive the exceptional service and partnership they have come to expect from Element. She holds a Ph.D. in biochemistry from Imperial College London, United Kingdom.

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