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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 112-7917028-1/2/2


Manufacturer FEI3006673777
Manufacturer NameSylphar N.V.  
Manufacturer Address line 1Xavier De Cocklaan 42  
Manufacturer Address line 2  
Manufacturer's CityDeurle  
Manufacturer Province/State  
Manufacturer Country/AreaBelgium  
Product Code53LY99  
FDA Product DescriptionOTHER SKIN CARE PREPARATIONS, N.E.C.  
Refusal Date09-Jul-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-7917028-1/2/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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