Recalls 101: New FDA Guidance Gives Basic Advice On Prepping For, Executing A Recall

The US FDA’s final guidance is a basic how-to guide for manufacturers to prepare for and roll out a product recall action.

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A new final guidance document from the US Food and Drug Administration offers manufacturers fundamental advice on how to prepare for and execute a product recall action.

“A firm that initiates a recall because it believes the product to be violative is requested to notify FDA immediately,” says the 3 March guidance, “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C.”

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