• 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 J89-0115765-3/1/3

Manufacturer FEI3006345820
Manufacturer NameMAXROTH IMPEX PVT LTD  
Manufacturer Address line 12ND FLOOR, NEELMANI CHAMBERS, B/H SALES  
Manufacturer Address line 2INDIA, ASHRAM ROAD, INCOMETAX  
Manufacturer's CityAHMEDABAD  
Manufacturer Province/StateIN-GJ  
Manufacturer Country/AreaIndia  
Product Code53LD03  
Importer's Product DescriptionBALM B IODEX  
Refusal Date14-Aug-2012  
FDA DistrictCHI-DO  
Entry/doc/line/sfx J89-0115765-3/1/3
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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.