This message was posted by a user wishing to remain anonymous
I represent company A who has just sold the assets of a legally marketed device (US only) to company B. Company A marketed the device in the US prior to all of this taking place. The transfer of assets includes finished goods inventory. Company A is in the process of transferring all the documentation (DHF, DMR, DHRs etc) to Company B.
Company B is essentially a shell company. I have advised that their entity needs to be registered with FDA (even although they will be contracting out most of their operations, including possibly some to Company A). They also need to list the device as at some point they will begin selling it under their own legal entity name.
The challenge is that because they are a shell company, they are starting from scratch and have no QMS. Is it acceptable for them to develop a Quality Plan that defines their roles and responsibilities as well as those their contractors will perform? I have advised that this plan will need to define the level of oversight that Company B will have over their contractors. They will not be purchasing parts directly, they will likely pay the contract mfr to do this for them.
My second concern is the transfer of inventory. Does Company B have to relabel the product that Company A mfd, tested, labeled and released to Finished Goods. I think they do but I was not sure what that labeling should say and if any qualifiers are required given that Company A did all the work prior to the transfer.
I appreciate any comments you may have.