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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 438-0810835-1/2/1


Manufacturer FEI3003079200
Manufacturer NameContinental Farmaceutica  
Manufacturer Address line 1Calle Jacinto Manon No 8  
Manufacturer Address line 2  
Manufacturer's CitySanto Domingo  
Manufacturer Province/State  
Manufacturer Country/AreaDominican Republic  
Product Code53LC03  
Importer's Product DescriptionFACIAL CREAM "SANTA CREAM"  
Refusal Date05-Dec-2011  
FDA DistrictSJN-DO  
Entry/doc/line/sfx 438-0810835-1/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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