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
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


. Without having any legal ownership, the "Customer" is controlling the Manufacturer#2. Why did the "Manufacturer#2" let it happen at first point! Didn't they realize that at some point they would get more new customers and would eventually expand! This is really a big issue, only thing you could do (as William has said) is just negotiate with both the parties or just simply change to a "Manufacturer #3"