Friday, October 4, 2019

FDA Releases New Draft Guidance Chapter - Recall Plan

FDA released a new guidance document on 'recalls' as part of a series of chapters on the FSMA regulation. This new document titled - Chapter 14: Recall Plan provides FDA's current thinking on what you need to do when writing your company's recall plan.
That document can be found here - https://www.fda.gov/media/131287/download

It would be a good idea to review this document to ensure your current plan reflects what FDA states for each of the elements.

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