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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 AEK-0334252-0/1/1

Manufacturer FEI3009444834
Manufacturer NameHerbaroma  
Manufacturer Address line 1Jl. Duren Tiga Selatan No. 5 Kalibata  
Manufacturer Address line 2  
Manufacturer's CityJakarta Selatan  
Manufacturer Province/State  
Manufacturer Country/AreaIndonesia  
Product Code53BY01  
Importer's Product DescriptionFOOT SCRUB SALTS  
Refusal Date11-Jun-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx AEK-0334252-0/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NO ENGLISH   502(c); 801(a)(3) ;MISBRANDING   Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).  
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).