• 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 112-8146216-3/1/1


Manufacturer FEI3004181110
Manufacturer NameSkin Sciences Laboratory, Inc.  
Manufacturer Address line 1Unit 101 Central Business Park  
Manufacturer Address line 2Amang Rodriguez Ave., Manggahan  
Manufacturer's CityPasig City  
Manufacturer Province/State  
Manufacturer Country/AreaPhilippines  
Product Code53IG01  
Importer's Product Description871683748354 TOOTHPASTE  
Refusal Date07-Aug-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-8146216-3/1/1
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).  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
-
-