• 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 H77-0134654-3/3/2


Manufacturer FEI3008985479
Manufacturer NameHemani International  
Manufacturer Address line 1Plot No. 11, Sector A-IV Karachi 75150  
Manufacturer Address line 2  
Manufacturer's CityKarachi  
Manufacturer Province/StateSindh  
Manufacturer Country/AreaPakistan  
Product Code53EH01  
Importer's Product DescriptionHAIR OIL  
Refusal Date26-Dec-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx H77-0134654-3/3/2
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.  
-
-