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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 M41-0783068-7/9/1/A


Manufacturer FEI3006672051
Manufacturer NameSabesa  
Manufacturer Address line 1Km 28 Carretera A Santa Ana  
Manufacturer Address line 2  
Manufacturer's CitySan Juan, Opico  
Manufacturer Province/State  
Manufacturer Country/AreaEl Salvador  
Product Code53EC01  
FDA Product DescriptionHAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)  
Refusal Date21-Dec-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx M41-0783068-7/9/1/A
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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