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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-0032182-6/1/1

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 Code53LD99  
Importer's Product DescriptionASEPXIA GEL  
Refusal Date26-Feb-2013  
FDA DistrictSWI-DO  
Entry/doc/line/sfx EDR-0032182-6/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).