La naturaleza nos respalda Bogota D.C., October 11 2004 Vi&i Lotwek Office of Nutritional Products, Labeling and Dietary Supplements (HFS-820) ; Center for Food Safety and Applied Nutrition j OC-j- 1 8 20P4 Food and Drug Administration t+- 5 100 Paint Branch Parkway College Park, MD, 20740-3835 Subject: Information requested on plant preparation processes. (Anamu and Vira vira) In the present package is included the information requested on October 7*, 2004 telephone conference. This includes a brief summary of the process the plant goes through before arriving at Naturasol, and the percentages of plant in each tablet of each plant. I also attached a copy of the S.O.P. (Standard Operative Procedure) formats for both plants, our IS09001 certificate, and a copy of our certificate of capacity of production expedited by the INVIMA (National Institute of Vigilance of Medicines and Food) each with its pertaining translation. We hope this answers your questions. With nothing further, we remain at your service. Department of Exterior Commerce Carrera 13 No. 46-56 P.B.X. 2 45 03 90 - 2 32 05 05 - 3 40 12 23 www.naturasol.net l Bogot6 Colombia Anamu Wild plant, grows in warm climates. l Partsused:leavesand stems.(cut 1Ocmaboveground) Process beforearriving at LaboratorioNaturasol l Washedin a solution 15%of calcium hypochloriteand water. l The plant is then doubledried in a stainlessstealoven at 45”C. l It is then milled in a stainlessmill and sifted througha 3 mm sift. l s Then it’ pulverizedand sifted througha 0.8 mm sift. l The plant materialis doublepackedin a 25 kg plastic bag with fiber cover. Naturasol). It is given an internal lot numberand shippedto final destination(Laboratorio After arriving at our installationsthe plant material: lgoesthroughan organoleptic chemist. inspectionby the pharmaceutical lRandommicrobiologicaltestsare done6 times a month. lIt is then storedin the prime materialswarehouse. lWhen a productionorderis issuedit goesthroughthe process on described StandardOperativeProcedure format (S.0.P). Contentof New Dietary Supplement: 89% in 500 mg. tablet. Tablet also contains 9% Starch, 1% Arabic Gum, 1% MagnesiumStereate. in Presentations bottlesof 60, 90 and 120tablets. Vira vira Wildplant, grows mainly in high mountam ranges, cold climates. l Parts used:leavesand stems.( cut 1Ocmaboveground) Process beforearriving at LaboratorioNaturasol lWashedin a solution 15% of calcium hypochloriteand water. lThe plant is then doubledried in a stainlesssteal oven at 45” C. lIt is then milled in a stainlessmill and sifted through a 3 mm sift. l s Then it’ pulverized and sifted through a 0.8 mm sift. lThe plant material is doublepackedin a 25 kg plastic bag with fiber cover. lIt is given an internal lot number and shippedto final destination(LaboratorioNaturasol). After arriving at our installations the plant material: lgoesthrough an organolepticinspectionby the pharmaceuticalchemist. lRandommicrobiological testsare done6 times a month. lIt is then storedin the prime materials warehouse. lWhen a production order is issuedit goesthrough the processdescribedon StandardOperativeProcedure format (S.0.P). Content of New Dietary Supplement:81.5% in 500 mg. tablet. Tablet also contains 16% Starch, 1.5% Arabic Gum, 1% Magnesium Stereate. in Presentations bottles of 60. 90 and 120 tablets.
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