Our 400 s/f GMP kratom cleanroom is comprised of a gowning area, quarantine and a main product production area. Our facility is FDA registered as a Dry Food Manufacturer. Processor and Packer for Dietary Supplements, Herbs and Botanicals.
We are current with local state and city regulations. Registered with the Oregon Dept. of Agriculture and have been inspected by ODA. We have been 3rd party audited for cGMP's by an independent company. We are a Qualified American Kratom Association GMP Vendor. The cleanroom itself is certified an ISO-7 production and quarantine area and ISO-8 gowning room.
In our cleanroom we sterilize every gram of kratom we sell. As known as Pasteurization. This not only eliminates any potential for salmonella but also drastically lowers yeast, mold, ecoli and enterobacteriaceae sometimes to levels undetectable on lab reports. We have validated this process thru our written validation procedures.
Lab testing Kratom is not only important but it is mandatory. We do internal macroscopic and organoleptic analysis of all our herbs. Our specifications are the same as AHPA ( American Herbal Products Association). Each batch is tested for salmonella, ecoli, heavy metals, yeast, mold and total coliforms. Providing safe kratom finished products.
We follow AHPA finished product standards. If a sample exceeds the thresh hold then that Lot is not used. All lab reports are available on request and held encase of FDA audit. We keep retention samples of all batches for 3 years as required by the FDA.
Product samples are also collected at various stages of production for chemical and microbiological analysis to ensure consistency and purity. Lot code confirmation, weight checks, label and material checks are performed according to exact written procedures.
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