• 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 234-0336477-3/6/4

Manufacturer FEI3003933402
Manufacturer NameRegisco Ent  
Manufacturer Address line 1Po Box Md 5 Madina  
Manufacturer Address line 2  
Manufacturer's CityAccra  
Manufacturer Province/State  
Manufacturer Country/AreaGhana  
Product Code53LC03  
Importer's Product DescriptionSIVO CLAIRE CREAME  
Refusal Date10-Aug-2004  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 234-0336477-3/6/4
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.