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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 322-3403287-1/2/1

Manufacturer FEI3002808507
Manufacturer NameWRP Asia Pacific Sdn Bhd  
Manufacturer Address line 1Lot 1, Jalan 3, Kawasan  
Manufacturer Address line 2Perusahaan Bandar Baru  
Manufacturer's CitySalak Tinggi, Sepang Selangor  
Manufacturer Province/State  
Manufacturer Country/AreaMalaysia  
Product Code80LYY  
Importer's Product DescriptionLATEX EXAM GLOVES  
Refusal Date21-Feb-2003  
FDA DistrictCHI-DO  
Entry/doc/line/sfx 322-3403287-1/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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.