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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 KM6-0055730-0/19/1

Manufacturer FEI3009614139
Manufacturer NameLigion Herbal Ltd  
Manufacturer Address line 144-F 4/2, Indira Road  
Manufacturer Address line 2  
Manufacturer's CityPanthapath, Dhaka-1215, Bangladesh  
Manufacturer Province/State  
Manufacturer Country/AreaBangladesh  
Product Code53FY99  
Importer's Product DescriptionMEHDI (HENA)  
Refusal Date09-May-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx KM6-0055730-0/19/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COLOR LBLG   602(e), 801(a)(3); MISBRANDING   The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.  
COSM COLOR   601(e), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).  
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.  
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