Investigations, Enforcement, & Compliance Alerts

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March 10, 2022

4 min read

FDA Issues Guidance to Clarify Recommendations Regarding Timely Initiation of Voluntary Recalls

Earlier this month, the Food and Drug Administration (“FDA” or “the Agency”) issued guidance to clarify how firms in a product distribution chain, including manufacturers and distributors, should establish voluntary-recall initiation procedures that ensure timely identification and notification of and responses to product problems.

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Winston & Strawn’s Investigations, Enforcement, & Compliance Alerts highlight and analyze significant issues and developments in government investigations, enforcement, civil and criminal trial defense and litigation, compliance, and related matters, providing insights on the legal and strategic implications for individuals and corporations conducting domestic and international business.