I agree with you that it never happens until it does. Unless you can eliminate all possible exceptions to ways to keep this quiet, the possibility remains. Posters on this board have demonstrated ways that exceptions can be utilized to do what has been suggested. It’s up to you to demonstrate that the exceptions do not apply. Best wishes.
Trying to dig a deep den, the fox hits rock just beneath the surface. Be gone with you animals of the hunt, and make way for the Mardi Gras parade rolling on in. Everybody’s dancing and there are fireworks, calliopes and even some clowns.
You do not have to make a filing public and FDA leaves that to a company to decide. You do have to make a rejection public and quite often it is due to not adequately preparing commercial manufacturing or its quality assurance. That is where a lot of companies get tripped up.
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