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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 300-5401942-5/2/1

Manufacturer FEI3001120513
Manufacturer NameKamins Dermatologics Inc  
Manufacturer Address line 1325 Av Stillview  
Manufacturer Address line 2  
Manufacturer's CityPointe Claire  
Manufacturer Province/StateQC  
Manufacturer Country/AreaCanada  
Product Code53LC10  
Importer's Product DescriptionMENOPAUSE SKIN CREAM (1.6 OZ / 45 G)  
Refusal Date27-Jan-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 300-5401942-5/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
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.