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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 MH7-7002362-9/19/2


Manufacturer FEI3009688282
Manufacturer NameKgl Services Express  
Manufacturer Address line 107 Bp 439  
Manufacturer Address line 2  
Manufacturer's CityAbidjan  
Manufacturer Province/State  
Manufacturer Country/AreaIvory Coast  
Product Code53IG01  
FDA Product DescriptionDENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)  
Refusal Date25-Sep-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx MH7-7002362-9/19/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
DR PACKGNG   502(i) (1), 801(a)(3); MISBRANDING   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be a drug and its container is so made, formed, or filled as to be misleading  
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
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