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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 112-4695768-7/4/1


Manufacturer FEI3003583637
Manufacturer NameGuangzhou Xianda Spectacles Manufacture Co. Ltd.  
Manufacturer Address line 1Xin Shi Town, Pin Sha Road  
Manufacturer Address line 2  
Manufacturer's CityNew Guangzhou  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code86HQY  
Importer's Product Description795320014521 SUNGLASSES  
Refusal Date25-Nov-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-4695768-7/4/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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