FDA Issues Voluntary Recalls Final Guidance

The guidance will help companies prepare to quickly and effectively remove violative products from the market, as the agency urges companies to be “recall ready” to protect public health.

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The FDA has finalized guidance to help companies prepare to quickly and effectively remove violative products from the market. The guidance describes steps companies should take to develop recall policies and procedures before a recall is necessary. These steps include training, planning, and record-keeping to reduce the time a recalled product is on the market to limit the public’s exposure to risk.

“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,” says Associate Commissioner of Regulatory Affairs Judith McMeekin, Pharm. D. “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 minimize Americans’ exposure to potentially harmful products.” 


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The Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C guidance explains how companies should have adequate product coding and maintain distribution records to facilitate faster, more accurate recall actions, and encourages recalling companies to use electronic communications to quickly identify and provide certain product information when alerting consignees and the public about a voluntary recall. 

The guidance also urges companies to act quickly to initiate a recall when public health is at risk and to do so prior to completing an investigation into the cause of the problem. Since recalls can affect the entire supply chain, including downstream suppliers, wholesalers, and vendors, the FDA recommends that companies develop recall procedures to quickly inform their entire distribution chain, so consignees can rapidly identify affected lots and recall downstream products when necessary. 


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