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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 XXX-0178345-6/2/2


Manufacturer FEI3002860216
Manufacturer NameLaboratorios Rysell S.A.  
Manufacturer Address line 1Carretera Mella Km 8 1/2 Lucerna  
Manufacturer Address line 2  
Manufacturer's CitySanto Domingo  
Manufacturer Province/State  
Manufacturer Country/AreaDominican Republic  
Product Code53JD04  
FDA Product DescriptionFEMININE DEODORANTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)  
Refusal Date28-Jun-2012  
FDA DistrictSJN-DO  
Entry/doc/line/sfx XXX-0178345-6/2/2
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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