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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-8204589-5/1/1


Manufacturer FEI3008376007
Manufacturer NameJolinie Cosmeceutical Inc.  
Manufacturer Address line 1141-269, 6200 Mckay Avenue  
Manufacturer Address line 2  
Manufacturer's CityBurnabyburnaby  
Manufacturer Province/StateBRITISH COLUMBIA  
Manufacturer Country/AreaCanada  
Product Code53LD06  
Importer's Product DescriptionMOISTURIZER INTENSIVE WHITENING  
Refusal Date19-Nov-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx UPS-8204589-5/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
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