• 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 F57-3797036-1/2/1


Manufacturer FEI3004737602
Manufacturer NameWillard Manufacturing Inc.  
Manufacturer Address line 15295 John Lucas Drive  
Manufacturer Address line 2  
Manufacturer's CityBurlington  
Manufacturer Province/StateOn  
Manufacturer Country/AreaCanada  
Product Code53ID01  
Importer's Product DescriptionFD AMBER MOUTH WASH  
Refusal Date29-Dec-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx F57-3797036-1/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
-
-