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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 408-1295602-4/6/1

Manufacturer FEI3009098401
Manufacturer NameYongding Company Limited  
Manufacturer Address line 1No. 402, Unit 4, Yinxiu Bldg. No. 031,  
Manufacturer Address line 2  
Manufacturer's CityYiwu City  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code86HQY  
Refusal Date22-Nov-2011  
FDA DistrictSAN-DO  
Entry/doc/line/sfx 408-1295602-4/6/1
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.  
NOT IMPACT   501(c), 801(a)(3); ADULTERATION   The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.