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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 112-4584287-2/2/3

Manufacturer FEI3007793393
Manufacturer NameRodial Ltd.  
Manufacturer Address line 1535 Kings Road  
Manufacturer Address line 2Suite 1.24 The Plaza  
Manufacturer's CityLondon  
Manufacturer Province/StateGB-LND  
Manufacturer Country/AreaUnited Kingdom  
Product Code53LC01  
Importer's Product Description492092011559 GLAM BALM HAND  
Refusal Date10-Feb-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-4584287-2/2/3
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
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.