FDA WARNING_LETTER - PurQuality, LLC - January 23, 2013

On December 4, 2013, the FDA issued a Warning Letter to PurQuality, LLC, following an inspection of their dietary supplement manufacturing facility in Tempe, Arizona, from January 14-23, 2013. The inspection revealed significant violations of FDA's Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their products adulterated. Additionally, TriMedica OsteoHelp and TriMedica Pure MSM products were found to be misbranded.

Key violations included: 1. Failure to establish product specifications for purity, strength, and contamination limits for finished dietary supplements, specifically for OsteoHelp and PURE MSM capsules. Responses regarding testing methods (FTIR) were deemed inadequate due to lack of scientific validity documentation. 2. Failure to conduct identity testing for incoming dietary ingredients, such as Vitamin D3 and MSM, prior to use. 3. Failure to establish the reliability of supplier Certificates of Analysis (COAs) through confirmation of results and to maintain documentation of supplier qualification. 4. Quality control personnel failed to ensure finished batches conformed to product specifications, releasing PURE MSM capsules and OsteoHelp before microbiological testing results were complete. 5. Quality control operations for laboratory results, specifically FTIR notebook documentation for raw material and finished product identity, were not reviewed and approved by QC personnel.

Misbranding violations included: 1.