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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 EK4-0508404-8/10/1


Manufacturer FEI3008963956
Manufacturer NameCederroth Polska Sa  
Manufacturer Address line 1Ul Polna 21  
Manufacturer Address line 2  
Manufacturer's CityRadzymin  
Manufacturer Province/StateMazowieckie  
Manufacturer Country/AreaPoland  
Product Code53LG08  
FDA Product DescriptionPASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)  
Refusal Date18-Apr-2012  
FDA DistrictCHI-DO  
Entry/doc/line/sfx EK4-0508404-8/10/1
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.  
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.  
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