• 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 557-1009087-3/1/6


Manufacturer FEI3004764454
Manufacturer NameCasa Granado Laboratorios Farmacias E Droganas Sa  
Manufacturer Address line 1Rua Do Lavatorio, 30  
Manufacturer Address line 2  
Manufacturer's CityRio De Janeiro  
Manufacturer Province/State  
Manufacturer Country/AreaBrazil  
Product Code62WAZ99  
Importer's Product DescriptionFOOT POWDER-ANTISEPTIC/ANTIPERSPIRANT/DEODORANT-PER T PINTO@PINTO TRDG  
Refusal Date04-Nov-2004  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 557-1009087-3/1/6
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.  
-
-