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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 112-7917028-1/3/1

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 Code53IY99  
Importer's Product Description972258025145 ORAL CARE  
Refusal Date09-Jul-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-7917028-1/3/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
INCONSPICU   403(f), 801(a)(3); MISBRANDING   Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.