New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans

On 23 April, Food and Drug Administration (FDA) issued draft guidance entitled "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C," which aims to clarify how firms in a product-distribution chain should prepare to facilitate timely initiation of a voluntary recall, respond to an indication of a problem with a distributed product, and initiate a voluntary recall.

Overall, FDA emphasizes the importance of pharmaceutical, biotechnology, medical device, food, tobacco, and animal products firms having made plans in advance of a recall so that they are prepared, should one become necessary.

Read More: New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans


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