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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 BD6-0007305-0/5/1

Manufacturer FEI1000183699
Manufacturer NameLaboratories La Prairie Sa  
Manufacturer Address line 1Industries 8  
Manufacturer Address line 2  
Manufacturer's CityVolketswil  
Manufacturer Province/State  
Manufacturer Country/AreaSwitzerland  
Product Code53LC06  
Refusal Date19-Dec-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx BD6-0007305-0/5/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
DIRSEXMPT   502(f)(1), 801(a)(3); MISBRANDING   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use. [Misbranded, Section 502(f)(1)]