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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 UPS-4246682-7/1/2


Manufacturer FEI3008995240
Manufacturer NameMateriel Medical And Co  
Manufacturer Address line 1594 Chemin De La Sourceespace Lumiere  
Manufacturer Address line 2  
Manufacturer's CityHyereshyeres  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53LC01  
Importer's Product DescriptionDERMALIBOUR MOUSSANT ANTI BACTERAIL SKIN CLEANSING GEL  
Refusal Date22-Nov-2011  
FDA DistrictPHI-DO  
Entry/doc/line/sfx UPS-4246682-7/1/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NO ENGLISH   502(c); 801(a)(3);Misbranding   Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)  
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
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