WASHINGTON – Timing is everything during a product recall, and with this in mind, the US Food and Drug Administration (FDA) issued draft guidance to help manufacturers prepare, plan and execute recalls without delays.
“Today’s 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,” said Melinda Plaisier, FDA's associate commissioner for regulatory affairs. “It builds upon 18 months of proactive and systematic improvements to the FDA’s recall processes.”
Titled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” the FDA’s recommendations fall into three key areas — training, record keeping and procedures.
In the area of training, the FDA’s new draft guidance advises companies on best practices to identify and train appropriate personnel on their responsibilities during a recall, establish a recall communications plan, and identify what FDA reporting requirements, among other things.
Effective record keeping could entail using technology such as blockchain. FDA also emphasizes the importance of properly coded products and maintaining distribution records in order to conduct the most effective recall possible
Finally, FDA recommends that companies prepare and maintain written recall initiation procedures to prevent delays in removing affected products from the market. Procedures should clearly describe the appropriate actions to take when a recall is initiated.
The new draft guidance follows several updates to the agency’s protocols surrounding product recalls. Previous enhancements include detailing situations where the FDA would disclose certain supply chain and retail distribution information during certain food recalls; guidance regarding mandatory food recall provisions; and 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.
FDA also adopted new policies for rapidly posting new recalls to the agency’s Enforcement Report, which is a web-based listing of all recalls monitored by the FDA.
“These efforts have made important improvements toward our goal of quickly executing recalls and reaching consumers with timely information to limit the impact of potentially dangerous products,” Plaisier said. “But we know there is more that needs to be done. Moving forward, the agency will continue its efforts to improve recalls, and will encourage the use of new technologies and other tools that can assist in those efforts.”
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