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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 438-0810973-0/24/1

Manufacturer FEI3009289916
Manufacturer NamePrima Cosmeticos  
Manufacturer Address line 1Encinitas Country 1  
Manufacturer Address line 2  
Manufacturer's CityCalifornia  
Manufacturer Province/StateCA  
Manufacturer Country/AreaUnited States  
Product Code53LC03  
Importer's Product DescriptionFACIAL CREAM "CREMA PRIMA"  
Refusal Date08-Mar-2012  
FDA DistrictSJN-DO  
Entry/doc/line/sfx 438-0810973-0/24/1
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.