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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 AMS-0002486-8/336/1


Manufacturer FEI3000243864
Manufacturer NameClarins  
Manufacturer Address line 14 Rue Berteaux Dumas  
Manufacturer Address line 2BP 174  
Manufacturer's CityNeuilly Sur Seine  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53LC10  
FDA Product DescriptionWRINKLE SMOOTHING (SKIN CARE PREPARATIONS)  
Refusal Date01-Oct-2012  
FDA DistrictFLA-DO  
Entry/doc/line/sfx AMS-0002486-8/336/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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).  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
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