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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 D01-0842449-6/2/6


Manufacturer FEI3004055664
Manufacturer NameUnilever de Mexico S de R.L. de C.V.  
Manufacturer Address line 1Calle 1 Norte  
Manufacturer Address line 2  
Manufacturer's CityJiutepec  
Manufacturer Province/StateMor  
Manufacturer Country/AreaMexico  
Product Code53GH02  
FDA Product DescriptionFACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES)  
Refusal Date26-Feb-2013  
FDA DistrictSWI-DO  
Entry/doc/line/sfx D01-0842449-6/2/6
FDA Sample AnalysisYes  
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).  
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.  
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