• 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 ASQ-0028069-0/2/1

Manufacturer FEI3009045310
Manufacturer NamePendura Inter Laboratories (Asia) Co Ltd  
Manufacturer Address line 16 Prasertmanukrit 29 Yak 10,  
Manufacturer Address line 2  
Manufacturer's CityBangkok  
Manufacturer Province/State  
Manufacturer Country/AreaThailand  
Product Code53JL01  
Importer's Product DescriptionCLEANSING BAR  
Refusal Date20-Oct-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx ASQ-0028069-0/2/1
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.