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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 KM6-0053484-6/13/2

Manufacturer FEI3006993135
Manufacturer NameTOHFA ENTERPRISE  
Manufacturer Address line 1DEWAN BARI  
Manufacturer Address line 2166, SHANTINAGAR (1st Floor)  
Manufacturer's CityDHAKA  
Manufacturer Province/StateBD-13  
Manufacturer Country/AreaBangladesh  
Product Code53ED07  
Importer's Product DescriptionTIBBOT MEDICATED OIL  
Refusal Date17-Oct-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx KM6-0053484-6/13/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.