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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 G01-0359101-5/1/3


Manufacturer FEI3009150406
Manufacturer NameELVA MEJIA COVARRUBIAS  
Manufacturer Address line 1Junipero Serra  
Manufacturer Address line 2OTAY BAJA CALIFORNIA  
Manufacturer's CityTijuana  
Manufacturer Province/StateBC  
Manufacturer Country/AreaMexico  
Product Code53BG99  
FDA Product DescriptionOTHER BATH PREPARATIONS, N.E.C.  
Refusal Date01-Apr-2013  
FDA DistrictSWI-DO  
Entry/doc/line/sfx G01-0359101-5/1/3
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COLOR LBLG   602(e), 801(a)(3); MISBRANDING   The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.  
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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