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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 084-1047592-8/33/1


Manufacturer FEI3004714518
Manufacturer NameNisa International  
Manufacturer Address line 1Adam Smith Street  
Manufacturer Address line 2  
Manufacturer's CityGrimsby  
Manufacturer Province/State  
Manufacturer Country/AreaUnited Kingdom  
Product Code53IG99  
FDA Product DescriptionOTHER ORAL HYGIENE PRODUCTS, WITHOUT FLUORIDE, N.E.C.  
Refusal Date12-Mar-2013  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 084-1047592-8/33/1
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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