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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 KM6-0056593-1/4/1


Manufacturer FEI3009059280
Manufacturer NameEtc International  
Manufacturer Address line 1House #163/D,Road #3,Mohammadihousing  
Manufacturer Address line 2  
Manufacturer's CityDhaka  
Manufacturer Province/State  
Manufacturer Country/AreaBangladesh  
Product Code53JY01  
FDA Product DescriptionBATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)  
Refusal Date14-Sep-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx KM6-0056593-1/4/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
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).  
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