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Letter from Naturasol to CFSAN with translation RPT257

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La naturaleza nos respalda Date: September24,2004 Bogota D.C., Colombia Att: Victoria Lotwek Office of Nutritional Products,Labeling, and Dietary Supplements(HFS-820) Center for Food Safety and Applied Nutritional Food and Drug Administration 5 100 Paint Branch Parkway College Park, MD, 20740-.3835 Subject: Missing copies - text translations Dear Ms. Lotwek: Here are 3 copies of the translation of the texts in Spanishfor both plants: Anamu and Vira vira. Once more thank you for your patience and help. If you need to contact us, pleasefeel free to call me (571) 232 05 05. Exterior Commerce Department Carrera 13 No. 46-56 P.6.x. 2 45 03 90 - 2 32 05 05 - 3 40 12 23 ,~J%A’ wxd.net . Boqotci Colombia IMI I*~ (TRANSL.A TION) TlME Finish start 11. Transfer powder in plastic containers with a properly sealedplaslic bag. 12. Presslablets in 16 station Manesty tnachiue with pmpex care and pmxd to: Weight and consistencycontml (register in PD.FR.72 format) Didmeler, height, and dkintegralion control (regisler in CC.FR. 1 format) 13. Solicit conditioning order (PD.FR65) 14. Transfer LOsolids bottling area ( tablets) in whhe PVC bottle Ref. 150 tile1 , and control the number of tablets on the counting scale by weight- Place push down cap on eachbottle. 15. Transfer to labeling area in plastic containers. 16. Verify the labek: Code Lot # Exp. Date Label color Print quality SIGNATURE AND DATE Verifm Effectuates - 17. Prod (0 label each bottk and place heat shrink tubing. 18. Seal using heat shrinking pistol, avoiding excessheat 19. Plastic w-rapin groups of 6 and place plastic containers. (register CC.FR.2) 20. Deliver lo finished product warehouse. PelfoImance: Expectedbottles ObtaincxJ bottlca Performance% Elaborated; operator: Supervised: P.L. Approved; T.C. - ‘ -.----A---- -- _--_ --- -

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