• 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 AZE-0049722-7/1/1


Manufacturer FEI3005773001
Manufacturer NameWenzhou Art & Creation Co Ltd  
Manufacturer Address line 125 Yucang Red Wenzhou Eco & Tech  
Manufacturer Address line 2  
Manufacturer's CityWenzhou  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code86HQY  
FDA Product DescriptionSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)  
Refusal Date02-Nov-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx AZE-0049722-7/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
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).  
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).  
-
-