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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 AM4-0224850-5/3/12

Manufacturer FEI3004117296
Manufacturer NameGlaxosmithkline Mexico, S.A. de C.V.  
Manufacturer Address line 1Calle 21-E #104  
Manufacturer Address line 2Jiutepec  
Manufacturer's CityMorelos  
Manufacturer Province/State  
Manufacturer Country/AreaMexico  
Product Code53LC06  
Importer's Product DescriptionHINDS ACLARADORA  
Refusal Date12-Dec-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx AM4-0224850-5/3/12
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COSMETLBLG   5(c)(3)(A); 801(a)(3) Misbranding   It appears the label does not bear the common or usual name of the cosmetic.  
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.  
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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