Editor's Note: This cGMP warning letter goes into detail about PurQuality's efforts to meet FDA observations with respect to various cGMP requirements. Note that FDA alleges that the company failed to establish purity specifications for finished products, specifically "You did not establish limits for heavy metal contamination in [AA] and [BB] capsules."
Food and Drug Administration
December 4, 2013
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility located at 1895 S. Los Feliz Dr, Tempe, Arizona, from January 14-23, 2013. During the inspection, our investigators found significant violations of FDA's Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. � 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements in 21 CFR Part 111. Furthermore, we have determined that your TriMedica Oseto Help™ and TriMedica Pure MSM products are misbranded with the meaning of section 403 of the Act [21 U.S.C. � 343]. You can find the Act and the referenced regulations through links in FDA's homepage at www.fda.gov. ...
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