2 replies to this topic

[rdquality]

Hello,

A company that had a previous registration with FDA is closing its registered facility and will outsource the entire production. The brand will be the same, but the operation model will change. Storage and inventory management will be done by a third-party. 

Would this company need a new registration with FDA? Update registration? No registration at all (since it is not manufacturing, storing, handling products directly)?

Thanks! 

 

 

[SQFconsultant]

While this may change in the future the current requirement given what you indicated is that the new entity will need a new registration. 

[rdquality]

While this may change in the future the current requirement given what you indicated is that the new entity will need a new registration. 

Even if they are not actually handling product? All the other third-party facilities are already registered.