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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 D52-9002453-3/1/2


Manufacturer FEI3002363237
Manufacturer NameJin Jin Marketing co.,ltd  
Manufacturer Address line 13333/16-17 Sudprasert Road, Bangklo,  
Manufacturer Address line 2Bangkorlaem  
Manufacturer's CityBangkok  
Manufacturer Province/StateBangkok  
Manufacturer Country/AreaThailand  
Product Code53ED06  
Importer's Product DescriptionSHAMPOO (CLEAN AND ITCH CONTROL)  
Refusal Date26-Oct-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx D52-9002453-3/1/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
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