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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 112-6518122-7/1/6


Manufacturer FEI3009428339
Manufacturer NameDoctor Duve Medical Skin Care  
Manufacturer Address line 1Perusastrasse 5  
Manufacturer Address line 2  
Manufacturer's CityMunich  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code53LD99  
FDA Product DescriptionOTHER SKIN CARE PREPARATIONS, N.E.C.  
Refusal Date20-Apr-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-6518122-7/1/6
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
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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