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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 112-9429367-9/1/20

Manufacturer FEI3003818446
Manufacturer NameLa Roche-Posay Laboratories Pharmaceutique (L.R.P)  
Manufacturer Address line 1Avenue Rene Lavayer  
Manufacturer Address line 2  
Manufacturer's CityLa Roche Posay  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53LD06  
Refusal Date07-Jun-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-9429367-9/1/20
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.