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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 112-4035584-2/9/2

Manufacturer FEI3004482036
Manufacturer NameSimpnicite Skin Care  
Manufacturer Address line 134 Commercial Rd  
Manufacturer Address line 2  
Manufacturer's CityNewstead  
Manufacturer Province/State  
Manufacturer Country/AreaAustralia  
Product Code53MD01  
Importer's Product Description818806622266/SUNTAN  
Refusal Date05-Aug-2004  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-4035584-2/9/2
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).