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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 AEK-9577417-6/1/1


Manufacturer FEI3006665014
Manufacturer NameCarmen Garcia  
Manufacturer Address line 1Calle El Clavel G-3  
Manufacturer Address line 2  
Manufacturer's CitySan Salvador  
Manufacturer Province/State  
Manufacturer Country/AreaEl Salvador  
Product Code54YCN99  
Importer's Product DescriptionCAMPOLON FORTE 220 ML SUPPLEMENTAL VITAMINS  
Refusal Date21-Feb-2008  
FDA DistrictFLA-DO  
Entry/doc/line/sfx AEK-9577417-6/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NO ENGLISH   403(f), 801(a)(3); MISBRANDING   Required label or labeling appears to not be in English per 21 CFR 101.15(c).  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
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