• 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 D52-4791590-8/1/1

Manufacturer FEI3008518747
Manufacturer NameGuangzhou Aillx Rubber Product Co., Ltd  
Manufacturer Address line 1Jin Lai Mansion, No 799 San Yuan Li Dao  
Manufacturer Address line 2  
Manufacturer's CityGuangdong  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code85HIS  
FDA Product DescriptionCONDOM  
Refusal Date01-Nov-2011  
FDA DistrictCHI-DO  
Entry/doc/line/sfx D52-4791590-8/1/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
DIRECTIONS   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use.  
HOLES   501(c); 801(a)(3) Adulteration   The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.  
NO 510(K)   801(a)(3); 502(o) Misbranding   It appears that a notice or other information respecting the device was not provided to FDA, as required by Section 510(k) and the device was not found to be substantially equivalent to a predicate device.  
NO PMA   501(f)(1)(B), 801(a)(3); ADULTERATION   The article appears to be a class III device without an approved application for premarket approval pursuant to section 515(a).  
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).