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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 574-0267371-9/5/1

Manufacturer FEI3009392910
Manufacturer NameLa Roche Possay  
Manufacturer Address line 1Georg-Glock Str 18  
Manufacturer Address line 2  
Manufacturer's CityDusseldorf  
Manufacturer Province/StateNordrhein-westfalen  
Manufacturer Country/AreaGermany  
Product Code53LC03  
Importer's Product DescriptionSKIN CREAMS IN PLASTIC TUBE  
Refusal Date11-Jun-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx 574-0267371-9/5/1
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.