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FDA Issues Update to Facility Registration Guidance and New Supplemental Draft Guidance
27 August 2018
The U.S. Food and Drug Administration (FDA) recently issued two guidance documents to assist establishments in determining whether they have an obligation to register as a food facility.
The first document is the finalized seventh edition of FDA’s Questions and Answers Regarding Food Facility Registration (Final Guidance). The second document is a supplemental draft guidance to the seventh edition (Supplemental Draft Guidance), which addresses which parties must register in situations where multiple entities share a physical space (e.g., a food manufacturer leases a building). The Supplemental Draft Guidance is open for comments through October 19, 2018. This memorandum summarizes the changes made in the Final Guidance since it was originally proposed in draft form in December 2016 and the new content in the Supplemental Draft Guidance.
Authored by Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham.
Washington, D.C.
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