FDA Establishment registration - Buying some medical devices from another manufacturer

#1
Hello all,
The company I work for is a medical device manufacturer company, but will buy some medical devices from another medical device manufacturer (#2) to complete product portfolio for the US market.

The #2 has not registered their establishment with the FDA, but a different party, which is another customer of #2, did registered the facility, and have shared with us the registration number, we have confirmed it has an active status with the FDA.

What I would like to ask is if there will be an issue if the establishment (#2) is registered by a different party, not by the #2 itself nor by my company.

Thanks
 
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#3
I see an issue here. It's the manufacturer (#2) who must register their facility, list their devices and pay for the registration fee and maintain the registration every year; not by their customer (the customer may wish to offer the payment for the manufacturer, there is no harm in it) as when FDA will go for an audit, they will visit the facility where devices have been manufactured. FDA's definition of "Manufacturer";
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And to my understanding, there is no such provision to "register" a facility on behalf of someone!

1590110738288.png

But in your case, if the "other customer" of "manufacturer #2" has some legal relationship and the customer legally owns the facility of the "manufacturer#2" in some way, then the customer can register the "facility" of the "manufacturer #2" on their behalf.
 
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