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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 ENM-9012178-1/7/3


Manufacturer FEI3008878813
Manufacturer NameSESDERMA SL  
Manufacturer Address line 1Pol. Industrial Rafelbunol  
Manufacturer Address line 2Calle Massamagrell 5  
Manufacturer's CityRafelbu┬┐ol  
Manufacturer Province/StateValencia  
Manufacturer Country/AreaSpain  
Product Code53ED06  
FDA Product DescriptionSHAMPOOS (HAIR PREPARATIONS, NON-COLORING)  
Refusal Date06-Jul-2012  
FDA DistrictSJN-DO  
Entry/doc/line/sfx ENM-9012178-1/7/3
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COSM COLOR   601(e), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).  
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