For a long time we have been in the secondary packaging business. Recently we have moved to the primary packaging business and some of our customers are informing us they are considering our secondary packaging product as primary due to its application in the consumer market.
We aren't registered currently with the FDA. Is this something we should look into pursuing? Or is it required now that we have moved to the primary packaging business? Our 3rd party and customer audits so far have not yielded any answer to this, and nothing on the FDA website is pointing exactly to the answer to my question.
I don't want to do more than necessary, but I also don't want us to be non-compliant because I was uninformed about details concerning our new process. Thank you in advance for your help.