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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-7888260-8/2/1/B


Manufacturer FEI3007018612
Manufacturer NameLabo. DERMA  
Manufacturer Address line 117, rue du colisee  
Manufacturer Address line 2  
Manufacturer's CityParis  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53JD01  
Importer's Product DescriptionFAIR & WHITE - SKIN CARE - SOAP  
Refusal Date16-Oct-2012  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-7888260-8/2/1/B
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
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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