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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 UPS-6624614-7/1/1/C

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 Code53LC03  
Importer's Product DescriptionCLEANANCE K ELIMINATION SPOTS CARE 40ML  
Refusal Date26-Jul-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx UPS-6624614-7/1/1/C
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).