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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 BJV-0233399-6/1/1

Manufacturer FEI3004710519
Manufacturer NameConvertors De Mexico  
Manufacturer Address line 1Calle Arcadias #1580 Col Terrazas De Val  
Manufacturer Address line 2  
Manufacturer's CityJuarez  
Manufacturer Province/State  
Manufacturer Country/AreaMexico  
Product Code80FQM  
Importer's Product DescriptionBANDAGE, HONEYCOMB ELAS 3IN  
Refusal Date07-Mar-2011  
FDA DistrictSWI-DO  
Entry/doc/line/sfx BJV-0233399-6/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
DE IMP GMP   801(a)(1); NON CONFORMING MANUFACTURING PRACTICES   The methods used in, or the facilities or controls used for the manufacture, packing, storage or installation do not conform to the requirements under section 520(f).  
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