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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 554-8424451-6/1/1

Manufacturer FEI3008657063
Manufacturer NameEnergizer Personal Care  
Manufacturer Address line 11190 N Us Highway 1  
Manufacturer Address line 2  
Manufacturer's CityOrmond Beach  
Manufacturer Province/StateFL  
Manufacturer Country/AreaUnited States  
Product Code53MD01  
Importer's Product DescriptionTANNING OIL  
Refusal Date01-Aug-2012  
FDA DistrictATL-DO  
Entry/doc/line/sfx 554-8424451-6/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
LABELING   Section 4(a); 801(a)(3) Misbranding   The article appears in violation of FPLA because of its placement, form and/or contents statement.