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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 551-0248664-0/8/5

Manufacturer FEI3006360316
Manufacturer NameArcania Apothecary  
Manufacturer Address line 1Old Cheese Dairy  
Manufacturer Address line 2West Horrington  
Manufacturer's CityWells  
Manufacturer Province/StateSomerset  
Manufacturer Country/AreaUnited Kingdom  
Product Code53JD01  
Importer's Product DescriptionSHOWER GEL AM 5L  
Refusal Date27-Aug-2012  
FDA DistrictNWE-DO  
Entry/doc/line/sfx 551-0248664-0/8/5
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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).  
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.