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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 EUV-0001538-0/3/10


Manufacturer FEI3008357570
Manufacturer NameRafael A. Castillo  
Manufacturer Address line 1Oll Tercera 33  
Manufacturer Address line 2  
Manufacturer's CitySanto Domingo  
Manufacturer Province/State  
Manufacturer Country/AreaDominican Republic  
Product Code53ED05  
Importer's Product DescriptionRINSE DR. C. CASPA 12 OZ  
Refusal Date20-Jan-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx EUV-0001538-0/3/10
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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