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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 EDR-0027578-2/1/1

Manufacturer FEI3008466399
Manufacturer NameGenomma Lab Internacional SAB de CV  
Manufacturer Address line 1Av Industrial Automotriz,  
Manufacturer Address line 2Esq Ind Pte MZ 4 LT 3 y 5,  
Manufacturer's CityEstado de Mexico  
Manufacturer Province/StateDona Rosa Lerma  
Manufacturer Country/AreaMexico  
Product Code53LC10  
Refusal Date31-Oct-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx EDR-0027578-2/1/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
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).