• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Refusal Report

  • Print
  • Share
  • E-mail

Refusal Details as Recorded in OASIS by FDA

for Refusal EVL-0313118-3/8/1

Manufacturer FEI3009176837
Manufacturer NameTaizhou Xinlong Ind & Trade Co.,Ltd  
Manufacturer Address line 19 Kaiyuan Road  
Manufacturer Address line 2  
Manufacturer's CityTaizhoutaizhou  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code86HQY  
Refusal Date08-Nov-2011  
FDA DistrictCHI-DO  
Entry/doc/line/sfx EVL-0313118-3/8/1
FDA Sample AnalysisNo  
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).