FDA Issues Supplemental Draft Guidance for Industry on Facility Registration

Posted by Matt Schmitt on 8/23/18 5:00 PM

On August 20, 2018, the U.S. Food and Drug Administration (FDA) issued a supplemental draft guidance for the industry regarding food facility registration.

The supplement answers questions regarding scenarios involving multiple entities using shared space:

  • Who should register if a manufacturer leases the building where it manufactures food?

  • Which entity should register if a manufacturer stores food in a self-storage warehouse?

  • Who should register when multiple manufacturers use a communal kitchen?

According to FDA, “…guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited,” and “do not establish legally enforceable responsibilities.”

 

The guidance document may be downloaded here:

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm615521.htm

Topics: FDA, Guidance

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