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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 AEK-0373848-7/1/1/A


Manufacturer FEI3009958975
Manufacturer NameKen'S Beauty And Wellness Shop  
Manufacturer Address line 19a Sto Tomas St  
Manufacturer Address line 2  
Manufacturer's CityPhilippines  
Manufacturer Province/State  
Manufacturer Country/AreaPhilippines  
Product Code53MD99  
FDA Product DescriptionOTHER SUNTAN PREPARATIONS (NOT SUNSCREEN), N.E.C.  
Refusal Date19-Jul-2012  
FDA DistrictCIN-DO  
Entry/doc/line/sfx AEK-0373848-7/1/1/A
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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