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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 071-0192892-2/8/212


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 Code53LC08  
FDA Product DescriptionPASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)  
Refusal Date24-Jul-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 071-0192892-2/8/212
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COSMETLBLG   5(c)(3)(B); 801(a)(3) Misbranding   It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.  
LABELING   Section 4(a); 801(a)(3) Misbranding   The article appears in violation of FPLA because of its placement, form and/or contents statement.  
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