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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 045-0324185-5/1/3


Manufacturer FEI3003232696
Manufacturer NameMiracilum S.A.  
Manufacturer Address line 1Ul. Zablocie 23  
Manufacturer Address line 2  
Manufacturer's CityKrakow  
Manufacturer Province/State  
Manufacturer Country/AreaPoland  
Product Code53LD03  
FDA Product DescriptionFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)  
Refusal Date11-Apr-2013  
FDA DistrictCHI-DO  
Entry/doc/line/sfx 045-0324185-5/1/3
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COSMETLBLG   5(c)(3)(A); 801(a)(3) Misbranding   It appears the label does not bear the common or usual name of the cosmetic.  
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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