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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 605-2535536-2/11/1

Manufacturer FEI3006988574
Manufacturer Address line 1PHASE 4, INDUSTRIAL AREA  
Manufacturer Address line 2JEDDAH,  
Manufacturer's CityJEDDAH  
Manufacturer Province/StateSA-02  
Manufacturer Country/AreaSaudi Arabia  
Product Code53CK03  
Importer's Product DescriptionEYELINER  
Refusal Date04-Oct-2012  
FDA DistrictBLT-DO  
Entry/doc/line/sfx 605-2535536-2/11/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
CONTAINER   601(d), 801(a)(3); ADULTERATION   The container appears to be composed, in whole or in part, of a poisonous or deleterious substance which may render the contents injurious to health.  
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.