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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 1No. 121 Xin Min Road,  
Manufacturer Address line 2Xin Min District, Chang An Town  
Manufacturer's CityDongguan Guangdong Prov  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code86HQY  
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.