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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 D01-0835743-1/1/1

Manufacturer FEI2000010864
Manufacturer NameCosbel S.A. de C.V.  
Manufacturer Address line 1Prol. Div. del Norte No. 5152  
Manufacturer Address line 2Col. San Bernardino  
Manufacturer's CityMexico  
Manufacturer Province/StateMX-DIF  
Manufacturer Country/AreaMexico  
Product Code53ED06  
Refusal Date21-Oct-2011  
FDA DistrictSWI-DO  
Entry/doc/line/sfx D01-0835743-1/1/1
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).