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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-6832552-4/1/1

Manufacturer FEI3009410249
Manufacturer NameRoduve Healthcare Solutions  
Manufacturer Address line 1's Gravenweg 318b  
Manufacturer Address line 2  
Manufacturer's CityNieuwerkerk Ad Ijssel  
Manufacturer Province/StateZuid-holland  
Manufacturer Country/AreaNetherlands  
Product Code53LD99  
Importer's Product DescriptionCLEAR SKIN MAX SKIN KITS {5PCS}  
Refusal Date14-Mar-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx UPS-6832552-4/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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).  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.