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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 112-4999589-0/3/2


Manufacturer FEI3005952467
Manufacturer NameCaregen Co Ltd  
Manufacturer Address line 1690-3 Geumjeong Dong  
Manufacturer Address line 2  
Manufacturer's CityGyeongi-Do  
Manufacturer Province/State  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53ED01  
Importer's Product Description877017927477 HAIR CONDITIONER  
Refusal Date24-Jan-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 112-4999589-0/3/2
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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