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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 ETK-0001744-9/3/1/A

Manufacturer FEI3009752200
Manufacturer NameZermat Internacional Sa De Cv  
Manufacturer Address line 1Calzada Melchor Ocampo 193 Torre 3 Piso  
Manufacturer Address line 2  
Manufacturer's CityMexico Df  
Manufacturer Province/State  
Manufacturer Country/AreaMexico  
Product Code53JI02  
Refusal Date27-Feb-2013  
FDA DistrictSWI-DO  
Entry/doc/line/sfx ETK-0001744-9/3/1/A
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).