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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 WR1-0177388-0/11/1

Manufacturer FEI1000113698
Manufacturer NameParbel Of Florida, Inc.  
Manufacturer Address line 16100 Blue Lagoon Dr S-200  
Manufacturer Address line 2  
Manufacturer's CityMiami  
Manufacturer Province/StateFL  
Manufacturer Country/AreaUnited States  
Product Code53CH03  
Importer's Product DescriptionEYE LINER  
Refusal Date28-Mar-2013  
FDA DistrictNYK-DO  
Entry/doc/line/sfx WR1-0177388-0/11/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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).