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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 112-6818492-0/1/1

Manufacturer FEI3003516020
Manufacturer NameDay Sun Industrial Corp.  
Manufacturer Address line 1NO. 6, LANE 110, SEC. 4,  
Manufacturer Address line 2HSI-MEN ROAD,  
Manufacturer's CityTainan  
Manufacturer Province/StateTW-TNN  
Manufacturer Country/AreaTaiwan  
Product Code86HQY  
Refusal Date06-May-2010  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 112-6818492-0/1/1
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.  
REGISTERED   502(o), 801(a)(3); MISBRANDING   It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).