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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 MC2-6275480-7/1/1


Manufacturer FEI3007143709
Manufacturer NameSHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD  
Manufacturer Address line 1TAITOU HUAIAN ROAD  
Manufacturer Address line 2  
Manufacturer's CitySHIJIAZHUANG CITY  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code80LYZ  
Importer's Product DescriptionGLOVE EXAM VINYL SM PF 100/BX 10BX/CS  
Refusal Date21-Nov-2011  
FDA DistrictCHI-DO  
Entry/doc/line/sfx MC2-6275480-7/1/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
HOLES   501(c); 801(a)(3) Adulteration   The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.  
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