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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 077-0400168-9/7/1


Manufacturer FEI3003680049
Manufacturer NameMarcon Avista  
Manufacturer Address line 191 Wolska St  
Manufacturer Address line 2  
Manufacturer's CityWarszawa  
Manufacturer Province/State  
Manufacturer Country/AreaPoland  
Product Code53LC03  
FDA Product DescriptionFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)  
Refusal Date09-Aug-2004  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 077-0400168-9/7/1
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.  
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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