FDA calls on firms to be ‘recall ready’ in final guidance

Regulatory NewsRegulatory News | 03 March 2022 |  By 

The US Food and Drug Administration (FDA) on Thursday finalized guidance to help regulated industry initiate prompt recalls of violative products. The guidance covers voluntary recalls of drugs, devices, biological products, food, cosmetics and tobacco.
The document addresses how firms should devise a recall communication plan and train personnel on executing a recall, as well as how companies should maintain distribution records and establish procedures for initiating a recall.
FDA made minor changes from a draft version issued in April 2019. (RELATED: FDA Works to Improve Voluntary Recall Processes, Regulatory Focus 23 April 2019)
“In addition to editorial changes made to improve clarity, changes from the draft to the final guidance include the addition of the terms correction and market withdrawal to the terminology section, the addition of language encouraging the use of electronic communications for conveying voluntary recall communications about FDA-regulated product, and the deletion of section IV,” which is the reference section at the end, the agency said in a Federal Register notice.
It is essential that firms are “recall ready” to ensure quick action on violative products, said an FDA official in announcing the guidance. “Voluntary recalls continue to be the fastest, most effective way for a company to correct or remove violative and potentially harmful products form the market to help keep consumer safe,” said Judith McMeekin, associate commissioner of regulatory affairs. “We will continue to work with companies to improve their recall procedures and minimize Americans’ exposure to potentially harmful products.”
A company may act on its own initiative or FDA may inform the company it is distributing a violative product and recommend its removal.
The guidance complements FDA’s efforts in recent years to improve the recall process, such as guidance on the public availability of lists of retail consignees to execute human and animal food recalls, industry guidance on mandatory recalls of human and animal foods, the issuing of  public warnings and notifications of recalls for FDA-regulated products, which makes reference to FDA’s weekly Enforcement Reports listing all product recalls.
Stakeholders complained FDA’s draft guidance was inconsistent with respect to Part 7 and Part 806, and that clarity and metrics were needed to assess recall plans and corrective actions. (RELATED: FDA Draft Guidance on Voluntary Recalls Draws Concern of Inconsistency, Regulatory Focus 28 June 2019)
Federal Register notice
Final guidance


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Tags: FDA, recalls

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