Inspections, Compliance, Enforcement, and Criminal Investigations


Note: For each recall action, the RES provides a single record that is initiated at the beginning of the recall with an Alert. The record is continually updated in order to provide information for the Recall Recommendation, Classification, FDA website posting, any updates, and finally, Termination. The RES requires submission of some information not previously required. As the RES is finalized, detailed instructions will be provided for district and center coordinators. At the present time, the information provided or requested in the following attachments remains pertinent and appropriate for all steps of the recall process.

Page Last Updated: 06/19/2015
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