FDA Publishes Draft Guidance on Initiation of Voluntary Recalls

FDA Publishes Draft Guidance on Initiation of Voluntary Recalls

Guidance provides ways to prepare, plan, and work with the FDA to ensure voluntary recalls are initiated properly and promptly.

April 23, 2019

For recalls to be effective and timely, companies be prepared in advance to take all necessary steps for when a recall is initiated. As part of its efforts to guide companies on steps needed to ready their facilities and staff for possible recall situations, FDA has issued a new draft guidance that, when finalized, will provide industry with clear information on ways to prepare, plan, and work with the FDA to ensure voluntary recalls are initiated properly and promptly.

The draft guidance, “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” includes recommendations in three key areas:

  • Training. Proper training of personnel is perhaps one of the most important elements to effectively executing a recall. The draft guidance provides recommendations for companies who manufacture or distribute FDA-regulated products to adopt in readying their staff for potential recall situations. Specifically, it advises companies on ways to best identify and train appropriate personnel on their responsibilities during a recall, establish a recall communications plan, and identify what FDA reporting requirements there may be, among other things.
  • Recordkeeping. Thorough and organized recordkeeping is especially important as the agency continues its efforts to improve recalls through product traceability by tapping into modern approaches such as blockchain technology to further advance our mission of protecting public health. The draft guidance advises companies on the importance of properly coding their products and maintaining distribution records in order to conduct the most effective recall possible
  • Procedures. Written recall initiation procedures help minimize delays created by uncertainty. For companies that initiate a recall, using initiation procedures can help reduce the amount of time a defective or potentially harmful product is on the market and that in turn reduces the potential exposure to consumers. For consignees of a company that initiates a recall, these procedures can help extend the recall quickly throughout the distribution chain. The guidance recommends that firms consider preparing and maintaining written recall initiation procedures to swiftly ensure their recalled products are removed from the market. These procedures should clearly describe the appropriate actions to take when a decision is made to initiate a recall. They should also help ensure that necessary actions are not overlooked and may minimize the disruptive effect a recall can have on a company’s operations.

The draft guidance reflects the latest step in the agency’s ongoing commitment to working with companies to quickly act to protect consumers from potentially dangerous products, the agency said. It builds upon 18 months of proactive and systematic improvements to the FDA’s recall processes, during which the agency alerted companies of the situations where the FDA would disclose certain supply chain and retail distribution information during certain human and animal food recalls; provided mandatory recall guidance for human and animal foods, which answered common questions about the mandatory food recall provisions; and issued final guidance on public warnings and notifications of recalls for all FDA-regulated products outlining specific circumstances in which the agency would expect a company to issue a public warning about a voluntary recall. The agency has also adopted new policies for moving forward with rapidly posting new recalls to the FDA’s Enforcement Report, which is a web listing of all recalls monitored by the FDA.