• 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-8935545-3/2/1

Manufacturer FEI3007026825
Manufacturer NameWhite Beauty Inc  
Manufacturer Address line 166 West City Plaza  
Manufacturer Address line 2  
Manufacturer's CityQuezon City  
Manufacturer Province/StatePH-NOTA  
Manufacturer Country/AreaPhilippines  
Product Code53JK01  
Importer's Product DescriptionPERSONAL USE METATHONE SOAP  
Refusal Date24-Apr-2012  
FDA DistrictSAN-DO  
Entry/doc/line/sfx AEK-8935545-3/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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.