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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 438-0810849-2/6/1


Manufacturer FEI3005444989
Manufacturer NameBoe Dominicana C X A  
Manufacturer Address line 1Aut Duarte Km 13  
Manufacturer Address line 2  
Manufacturer's CitySanto Domingo  
Manufacturer Province/State  
Manufacturer Country/AreaDominican Republic  
Product Code53ED01  
FDA Product DescriptionHAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)  
Refusal Date05-Dec-2011  
FDA DistrictSJN-DO  
Entry/doc/line/sfx 438-0810849-2/6/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.  
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