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