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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 G01-0328299-5/3/1

Manufacturer FEI3004661547
Manufacturer NameCentral Botanica del Nayar, S.A. de C.V.  
Manufacturer Address line 1Av. Juarez No. 1640-B Col. Obrera  
Manufacturer Address line 2  
Manufacturer's CityEnsenada  
Manufacturer Province/StateMX-BCN  
Manufacturer Country/AreaMexico  
Product Code53LD03  
Importer's Product DescriptionTEPEZCOHUITE BODY CREAM  
Refusal Date30-Dec-2011  
FDA DistrictSWI-DO  
Entry/doc/line/sfx G01-0328299-5/3/1
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.  
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.  
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