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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 KM6-0058659-8/9/3


Manufacturer FEI3009566734
Manufacturer NameSudhir Sheth  
Manufacturer Address line 156, Chakla Street, 3rd Floor,R. No. 21  
Manufacturer Address line 2  
Manufacturer's CityMumbai  
Manufacturer Province/State  
Manufacturer Country/AreaIndia  
Product Code53JY01  
FDA Product DescriptionBATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)  
Refusal Date18-Sep-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx KM6-0058659-8/9/3
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.  
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).  
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