Well this is a very tricky situation…
The company that I am working for has an organizational structure that at the moment doesn’t cover the “manufacturer – contract manufacturer” demands.....
The existing
510k was issued initially only for this facility....
Latter on the company acquired also a facility in the US and they decided (without consulting the RA department) to change the ownership of this 510k and register both facilities as manufacturer and contract manufacturer simultaneously. So, there seems to be two manufacturers/contract manufacturers under the same. How can that even be possible?
Are my thoughts correct or am I missing something?