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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 U16-4661948-0/19/1

Manufacturer FEI3008885919
Manufacturer NameRobin Group Xxi S.L.  
Manufacturer Address line 1Calle Okila 17  
Manufacturer Address line 2  
Manufacturer's CityGetxo  
Manufacturer Province/StateVizcaya  
Manufacturer Country/AreaSpain  
Product Code53JA02  
Refusal Date09-Jan-2013  
FDA DistrictBLT-DO  
Entry/doc/line/sfx U16-4661948-0/19/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
COSMETLBLG   5(c)(3)(A); 801(a)(3) Misbranding   It appears the label does not bear the common or usual name of the cosmetic.  
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.