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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 FB2-0398701-1/1/1

Manufacturer FEI3008517911
Manufacturer NamePilot Optics International Corp., Ltd., Wenzhou  
Manufacturer Address line 16th Floor, Guo-da Plaza, Airport Road  
Manufacturer Address line 2  
Manufacturer's CityWenzhou  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code86HQY  
Refusal Date02-Nov-2011  
FDA DistrictSWI-DO  
Entry/doc/line/sfx FB2-0398701-1/1/1
FDA Sample AnalysisYes  
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.