FDA Releases Guidance On Initiating Voluntary Recalls

The U.S. Food and Drug Administration (FDA) has issued draft guidance on initiating voluntary recalls of food and other agency-regulated products. The guidance discusses:

(i) “what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures”;

(ii) “preparations firm in the distribution channel should consider making to ensure timely responses to a recall communication”; and

(iii) “how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws administered by the FDA.”

Comments on the draft guidance will be accepted until June 24, 2019.

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