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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 315-8611699-3/1/1


Manufacturer FEI3005817361
Manufacturer NameUnion Swiss  
Manufacturer Address line 19th Floor Park On Long  
Manufacturer Address line 2  
Manufacturer's CityCapetown  
Manufacturer Province/State  
Manufacturer Country/AreaSouth Africa  
Product Code53LD03  
Importer's Product DescriptionCOSMIX COSMETIC PREPARATION IN DRUMS  
Refusal Date03-Nov-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx 315-8611699-3/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COSM COLOR   601(e), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).  
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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