• 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 G08-0028237-1/11/5

Manufacturer FEI3002832061
Manufacturer NameWhitman Laboratories Ltd.  
Manufacturer Address line 1Winchester Road Hants EU 32 3DD  
Manufacturer Address line 2  
Manufacturer's CityPetersfield  
Manufacturer Province/State  
Manufacturer Country/AreaUnited Kingdom  
Product Code53LD03  
Importer's Product DescriptionANR WHITENING AND EYE  
Refusal Date29-Feb-2012  
FDA DistrictMIN-DO  
Entry/doc/line/sfx G08-0028237-1/11/5
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.