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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal 918-0405684-3/1/2

Manufacturer FEI3002616922
Manufacturer NameSalud Natural Mexicana SA de CV  
Manufacturer Address line 1Av. Inglaterra 3109  
Manufacturer Address line 2Col. Arcos Sur  
Manufacturer's CityGuadalajara  
Manufacturer Province/StateJalisco  
Manufacturer Country/AreaMexico  
Product Code41BGT99  
Importer's Product DescriptionCALTRON D SUSP. 360ML  
Refusal Date14-Dec-2005  
FDA DistrictSWI-DO  
Entry/doc/line/sfx 918-0405684-3/1/2
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
COLOR LBLG   403(k), 801(a)(3); MISBRANDING   The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.  
UNSAFE COL   402(c), 801(a)(3); ADULTERATION   The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).