Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 AEK-0381469-2/3/1

Manufacturer FEI3007121606
Manufacturer NameSkin Sciences Labo  
Manufacturer Address line 1Unknown Street  
Manufacturer Address line 2  
Manufacturer's CityPasig City  
Manufacturer Province/State  
Manufacturer Country/AreaPhilippines  
Product Code53IC01  
Importer's Product DescriptionTOOTHPASTE  
Refusal Date20-Jul-2012  
FDA DistrictCIN-DO  
Entry/doc/line/sfx AEK-0381469-2/3/1
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).  
-
-