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ATF yield vs. actual yield

ATF formula yield FDA

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#1 matthewcc

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Posted 06 November 2018 - 11:33 PM

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).

 

 

Thank you,
 

Matthew



#2 Scampi

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Posted 07 November 2018 - 06:25 PM

hi Matthew

No experience here, but i'm curious why your following an ATF rule when you're regulated by the FDA? or are you governed by both?


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#3 matthewcc

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Posted 07 November 2018 - 08:40 PM

Yes, we are governed by both.  ATF is for alcohol tax revenue and FDA is for almost all of our end-products.



#4 Scampi

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Posted 08 November 2018 - 08:35 PM

ok, so what you are asking is---how to you explain away the difference?  

 

Since you're above what you told the ATF you would be, is there any way you can rework the product to get it in line with what it should be?  Can you add distilled water?

 

I'm guessing yours in a purly regulatory question and that in it's  current state your product wouldn't harm anyone, you just don't want to feel their wrath?


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#5 matthewcc

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Posted 16 November 2018 - 05:30 PM

@Scampi

 

I think that we can often filter to remove excess sediment that gets the yield more in-line with what it should be, theoretically.

 

Yes, it's purely a regulatory question.  This is not a product safety issue.  I think often we'll be able to filter and get it into the "right" range, but if not, then we might have to write a deviation report or something.







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