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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 112-4160418-5/1/1

Manufacturer FEI3009140137
Manufacturer NameNew River  
Manufacturer Address line 1Buji Town Long Gang Ind Zone  
Manufacturer Address line 2  
Manufacturer's CityShenzhen  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code95RES  
Importer's Product Description876728669659 KEY CHAIN WITH LASER POINTER  
Refusal Date23-Nov-2011  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 112-4160418-5/1/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NO REGISTR   536(a); Failure to file initial report   The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).  
NO TAG   536(a),(b); NOT CERTIFIED   It appears that the article does not have affixed to it a certification in the form of a label or tag in conformity with section 534(h).