FDA urges companies to be ‘recall ready’

March 4, 2022

The U.S. Food and Drug Administration (FDA) issued a guidance document outlining steps for companies to take to quickly remove problematic products from the market.

The guidance focuses on steps companies should take to develop recall-ready policies and procedures that include training, planning and record-keeping. The guidance also urges companies to act quickly to initiate a recall prior to completing an investigation into the cause of the problem.

Because recalls can affect the entire supply chain, including downstream suppliers, wholesalers or vendors, the FDA said companies should develop recall procedures to quickly inform their entire distribution chain, so affected lots can be recalled and removed from the market.

“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,” said 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.”  

To initiate a recall, a company may act on its own initiative or in response to a recommendation from the FDA. The agency has the authority to require recalls of certain products, such as controlled substances, biological products, human cells, tissues and cellular and tissue-based products, medical devices, and food.

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