Should an Initial Importer separately do Establishment Registration?

SGquality

Quite Involved in Discussions
#1
My question is around the Establishment Registration

If the medical device organization with its Corporate Office in Massachusetts registers as a Specification Developer as they have a contract manufacturer in China. The finished device from China will be shipped to their Distribution Center in Arizona.

Does the organization have to separately do Establishment Registration for their Corporate facility in MA and their Distribution Center in AR or a single Establishment Registration would be acceptable?
 
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#2
Hi SGQuality,

We went through an exercise where we struggled with the definition of facility/establishment earlier this year, although we were trying to divide one site into separate facilities. So hopefully I can provide you some insight.

From what you've said, because the physical location of the Initial Importer is separate from your Specification Developer, you should register them as separate facilities in the FURLS database. The practical test we used was whether we could, under the Dun & Bradstreet criteria as we understood them, get a separate DUNS number for the locations. In that case, we could not. In your case, it really sounds like you could and should.

How you structure the registrations will probably affect your registration fees so be careful there. I have found the FDA to be extremely helpful when it comes to these kinds of technical questions. They understand that it is difficult to understand and also advised us not to register until the annual registration period in order to save money, which was kind of them.

Hope this helps.
 
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