Quality Control

Optimox® uses only the purest raw materials available, and has implemented strict quality control procedures in every stage of production, including inspection of raw materials, manufacturing, packaging, and storing. Optimox® is licensed under Allergy Research Group® by the State of Utah Department of Agriculture and Food, Certificate of Registration for Food Establishment number 190455 and US FDA registration number 19516500330. Optimox® is certified as a GMP manufacturer by NSF International, certificate number C0550075-DS-1.

GMP Standards

Our products are manufactured under FDA regulations at 21 CFR part 111 and comply with Dietary Supplement current Good Manufacturing Practices (cGMP). The GMP standards are applied to a wide variety of procedures associated with the manufacturing of dietary supplements, including receiving, testing, and approval of raw materials, production, and process controls, laboratory testing of labeled and packaged finished product, distribution control and accountability, and shelf life expiration testing to ensure freshness and potency.

For many years we have used the same manufacturers to produce our powder formulas, capsules, tablets, softgels, gels, and liquid products to ensure consistency. All of our certified manufacturers meet or exceed cGMP requirements established by the FDA, as well as state and local regulations. In our facility in South Salt Lake City, Utah, our highly trained staff bottle, label, and ship our finished products. Our newly installed automatic bottling line has multiple built-in quality checks, such as weight verification and metal detection, to ensure all finished packaged products have the pre-determined physical count and are contaminant-free.

Independent Third Party Laboratories

In addition to our in-house quality control department, we use certified independent analytical laboratories to test raw materials as well as finished products. All of our certified laboratories meet or exceed cGMP requirements. These labs include, but not limited to: Advanced Labs, Alkemist Labs, Aemtek, Avanti Polar Lipids, Covance, Chemical Solutions Ltd, ChromaDex, Craft Technologies, Eurofins, MicroQuality Labs, Venture Labs, etc. Our products are assayed for identity, purity and potency, and are confirmed to contain pre-determined amounts of the contents listed on every label. Microbial, pesticides/herbicides, aflatoxins, residual solvents, and heavy metals analysis are also conducted on all applicable products. A link to the recent results from tests such as these can now be found on each product page on the resources panel, when applicable.

Procedures of Analysis

We utilize a number of advanced methods of analysis, including high performance liquid chromatography (HPLC), IR and UV-VIS spectroscopy, capillary electrophoresis (CE), inductively coupled plasma-mass spectrometry (ICP-MS), atomic absorption (AA), thin layer chromatography (TLC), Fourier transform infrared spectroscopy (FTIR), DNA analysis, GMO-Testing, major food allergen testing, and radiation contamination testing along with biochemistry and wet chemistry techniques.