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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 112-8599584-3/1/1

Manufacturer FEI3005998665
Manufacturer NameSt. Dalfour Freres  
Manufacturer Address line 1B.P.N. 95  
Manufacturer Address line 2  
Manufacturer's CityCedex  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53LC99  
Importer's Product Description942532852856 WHITENING CREAM  
Refusal Date19-Oct-2007  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-8599584-3/1/1
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.  
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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