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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 112-9884344-5/1/2

Manufacturer FEI3007972613
Manufacturer NameMadara Cosmetics  
Manufacturer Address line 1Sampetera 2  
Manufacturer Address line 2  
Manufacturer's CityRiga  
Manufacturer Province/StateRiga  
Manufacturer Country/AreaLatvia  
Product Code53LD01  
Importer's Product Description857873731030 FIRMING OIL  
Refusal Date03-Nov-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-9884344-5/1/2
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.