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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-5873587-5/1/1/E

Manufacturer FEI3004102195
Manufacturer NameCrystal Clear International Ltd  
Manufacturer Address line 125 Rodney Street  
Manufacturer Address line 2  
Manufacturer's CityLiverpool  
Manufacturer Province/State  
Manufacturer Country/AreaUnited Kingdom  
Product Code53LD99  
Importer's Product DescriptionSOOTHING GEL, TONIC, POLISH, ETC  
Refusal Date23-Apr-2012  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-5873587-5/1/1/E
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).