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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 UPS-3985186-6/1/1/D

Manufacturer FEI3004474609
Manufacturer NameCosmeticos Elicina LTDA.  
Manufacturer Address line 1Padre Orellana 1319  
Manufacturer Address line 2  
Manufacturer's CitySantiago  
Manufacturer Province/State  
Manufacturer Country/AreaChile  
Product Code53LC99  
Importer's Product Description384 ELICINA CREAMS 40 GRS,144 PLUS,  
Refusal Date24-Oct-2011  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-3985186-6/1/1/D
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).