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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 231-3209964-3/1/1

Manufacturer FEI3005817986
Manufacturer NameWenzhou Lucheng Foreign Trade Co Ltd  
Manufacturer Address line 120e Wuhua Mansionxincheng District  
Manufacturer Address line 2  
Manufacturer's CityWenzhou  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code86HQY  
Refusal Date25-Nov-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 231-3209964-3/1/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NOT IMPACT   501(c), 801(a)(3); ADULTERATION   The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.  
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).