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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 EE6-7192694-1/2/7

Manufacturer FEI3004491807
Manufacturer NameHarmeling Sports  
Manufacturer Address line 1Energiestraat 19  
Manufacturer Address line 2  
Manufacturer's CityNijverdal  
Manufacturer Province/State  
Manufacturer Country/AreaNetherlands  
Product Code53LD99  
Importer's Product DescriptionCHAMOIS BALM - SKIN PROTECTOR - NO SPF  
Refusal Date27-Sep-2012  
FDA DistrictCHI-DO  
Entry/doc/line/sfx EE6-7192694-1/2/7
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.