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U.S. Department of Health and Human Services

Import Refusal Report
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Refusal Details as Recorded in OASIS by FDA

for Refusal UPS-6833355-1/9/1

Manufacturer FEI3008468427
Manufacturer NameWf Limited  
Manufacturer Address line 1No. 28 S. Roy Road  
Manufacturer Address line 2  
Manufacturer's CityKolkata  
Manufacturer Province/State  
Manufacturer Country/AreaIndia  
Product Code53IG01  
Importer's Product DescriptionNEAM TOOTH PASTE  
Refusal Date08-Jun-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx UPS-6833355-1/9/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
DIRECTIONS   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use.  
FRNMFGREG   502(o), 801(a)(3); MISBRANDING   The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&CA. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act. [Misbranding, Section 502(o), 801(a)(3)].?  
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.  
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