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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 JN4-0067369-3/4/3

Manufacturer FEI3008766427
Manufacturer NameAzzeen  
Manufacturer Address line 19 20 Ikedamachi  
Manufacturer Address line 2  
Manufacturer's CityNishinomiya-shi  
Manufacturer Province/StateHyogo-ken  
Manufacturer Country/AreaJapan  
Product Code53LD03  
Importer's Product DescriptionMOIST LOTION  
Refusal Date05-Feb-2013  
FDA DistrictLOS-DO  
Entry/doc/line/sfx JN4-0067369-3/4/3
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
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).  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.