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FDA Problem regarding Product Specification

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Posted 18 September 2018 - 07:47 PM



My facility is SQF certified and was recently visited by the FDA.  The "finished Product" specifications that were suffice for SQF were not enough for the FDA.  Particularly they sent us a warning saying that "we had failed to establish specifications for each dietary supplement for identity, purity, strength and composition. I do have finished product specs that include all of the ingredients, components, labeling, storage, etc and I am unsure what they want further?  I send my product off for heavy metal and micro testing every run, and have specs on what I allow for my limits.  I also have all of my ingredients ID tested and assayed for purity. That is not what he is looking for.  Any ideas? 

Edited by Charles.C, 19 September 2018 - 01:37 PM.
split from thread 15433



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Posted 19 September 2018 - 01:02 PM

do your specs say what % of the whole each ingredients is?


If the wording is straight from the regs then odds are you are missing one item...........i'm surmising that sine you said components, but not actual "recipe" the composition may be what they are after

Edited by Scampi, 19 September 2018 - 01:03 PM.

Please stop referring to me as Sir/sirs


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Posted 19 September 2018 - 04:28 PM



After reading the issue you are dealing with, it got me thinking that the same thing could happen to me (only been SQF Practitioner for 4 months). I found this PDF for clarifying differences between SQF Level 2 and FDA requirements. The PDF is from Leavitt Partners Executive Summary. 




I hope this helps you as much as it did for me. 

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