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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 DP6-0235005-1/3/1

Manufacturer FEI3004080633
Manufacturer NameNew Prosperity Optical Manufactory Ltd.  
Manufacturer Address line 1North Xin Xing Road,  
Manufacturer Address line 2Xin Min District, Chang An Town  
Manufacturer's CityDongguan, Guangdong Prov.  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code86HQY  
Importer's Product DescriptionSUNGLASSES  
Refusal Date17-Nov-2011  
FDA DistrictSAN-DO  
Entry/doc/line/sfx DP6-0235005-1/3/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
LENS CERT   502(a), 801(a)(3); MISBRANDING   The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.