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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 112-9199707-4/1/1

Manufacturer FEI3008541779
Manufacturer NameClemens Heinrich Kobrak  
Manufacturer Address line 1Rua 18 De Outubro 429 905  
Manufacturer Address line 2  
Manufacturer's CityTijuca  
Manufacturer Province/State  
Manufacturer Country/AreaBrazil  
Product Code53YY99  
Importer's Product Description873457865533 HAIR COLOR KITS  
Refusal Date06-Jan-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-9199707-4/1/1
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.