April 25, 2019

FDA issues draft guidance on initiating voluntary recalls

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA) on April 23 issued a new draft guidance to help manufacturers avoid delays in preparing, planning, and executing voluntary recalls.

The guidance includes recommendations in three areas:

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  • proper training of personnel
  • thorough and organized record keeping
  • written recall initiation procedures.

The guidance is the latest step in the agency’s commitment to working with companies to quickly act to protect consumers from potentially dangerous products, the FDA says.


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