Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C

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The purpose of this guidance is to assist and provide recommendations to industry and FDA staff regarding the use, content, and circumstances for issuance of public warnings and public
notifications for firm-initiated or FDA-requested recalls under 21 CFR Part 7, Subpart C – Recalls (Including Product Corrections) –Guidance on Policy, Procedures, and Industry Responsibilities. The guidance also discusses what information should be included in a public warning, as well as the parties responsible for issuing it. It represents FDA’s current thinking on public warning and notification of recalls under 21 CFR Part 7.

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