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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 071-0192892-2/8/97

Manufacturer FEI1000270679
Manufacturer NameLaboratorium Kosmetyczne Dr Irena E  
Manufacturer Address line 1Armii Krajowej 12  
Manufacturer Address line 2  
Manufacturer's CityPiaseczno  
Manufacturer Province/State  
Manufacturer Country/AreaPoland  
Product Code53LC03  
Importer's Product DescriptionBALSAM BODY BALM  
Refusal Date24-Jul-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 071-0192892-2/8/97
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).  
LABELING   Section 4(a); 801(a)(3) Misbranding   The article appears in violation of FPLA because of its placement, form and/or contents statement.