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'Mock' Recalls Suggested, But US FDA Isn't Joking About Recalling Products

 
• By Malcolm Spicer

FDA's suggestions in voluntary recalls draft guidance largely track with advice attorneys long have offered consumer health product firms. Instead, on top of November guidance on mandatory recall authority and February guidance on recall public notifications, FDA is making clear its expectations for firms' preparedness for recalls and their responses when faced with removing products from store shelves.

Recalls

Any doubts about the US Food and Drug Administration's expectations for regulated industries' compliance with its recall regulations should end as it publishes its third guidance in six months on firms' responsibilities for removing noncompliant products from the market.

The agency's voluntary recalls draft guidance includes training among it suggestions – not only training employees but also training a...

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