Hi there, I didn't see this topic posted anywhere, so I'll give it a go:
Has anyone ever had a conflict between a formula yield that one should achieve for the ATF (United States Bureau of Alcohol, Tobacco, and Firearms)--a formula filed with ATF--and an actual yield? We are facing this type of situation, and I don't know how it's typically handled. We have a greater actual yield than we should have compared to the ATF formula, even allowing for a (not-so-generous) +/-5% above and below.
I can think of a deviation document we could write, or possible changes to our batch production records, but I don't know if this is the best way to reconcile two different numbers.
This is for a liquid, a dietary supplement extract (tincture) that contains ethanol and plant material; this is in the United States, regulated by the Food and Drug Administration (FDA).