Establishment registration - Starting to split the business into seperate divisions

[sherlok]

Hi
I work for a medical device manufacturer based outside the US. Due to growth we are starting to split the business into seperate divisions, with a common QMS. In the coming months one of the divisions will move to a new building and this has lead to the question of whether we should register this as a seperate establishment.
Has anyone had experience of a similar situation? is it even possible? the perceived benefits are that if one division did run into difficulties with the FDA, the other divisions (provided we develop a more independant QMS in each) would be unaffected. We would be considered a small manufacturer by US standards <1000 employees

Thanks, Kevin

[Marc]

What standard are you referring to?

[Al Rosen]

Originally Posted by sherlok

Hi
I work for a medical device manufacturer based outside the US. Due to growth we are starting to split the business into seperate divisions, with a common QMS. In the coming months one of the divisions will move to a new building and this has lead to the question of whether we should register this as a seperate establishment.
Has anyone had experience of a similar situation? is it even possible? the perceived benefits are that if one division did run into difficulties with the FDA, the other divisions (provided we develop a more independant QMS in each) would be unaffected. We would be considered a small manufacturer by US standards <1000 employees

Thanks, Kevin

I believe if you read the regulation, 21cfr807.40, for foreign establishments you will see you can have only one US agent. So your scheme to do an end run around the law will not succeed since it does not matter how many buildings you have registered. BTW, you need to register each location. The entire regulation can be found in Part 807.

[Al Rosen]

Originally Posted by Marc

What standard are you referring to?

Marc, it must be the FDA QSR, 21cfr820, as far as the FDA is concerned.