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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 UPS-3992451-5/1/1/A

Manufacturer FEI3009072097
Manufacturer NameKerastraight Ltd  
Manufacturer Address line 11063 Ave Jaime Vignoli  
Manufacturer Address line 2  
Manufacturer's CityPorto Alegreporto Alegre  
Manufacturer Province/State  
Manufacturer Country/AreaBrazil  
Product Code53ED99  
Importer's Product DescriptionKERASTRAIGHT SMOOTHING HAIR PREP  
Refusal Date10-Nov-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx UPS-3992451-5/1/1/A
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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).  
COSMETLBLG   5(c)(3)(B); 801(a)(3) Misbranding   It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.  
LABELING   Section 4(a); 801(a)(3) Misbranding   The article appears in violation of FPLA because of its placement, form and/or contents statement.  
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