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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 277-0133750-6/6/1


Manufacturer FEI3002003042
Manufacturer NameTwin Lotus Co. Ltd.  
Manufacturer Address line 1999 Moo 7 Bangchalong Bangplee  
Manufacturer Address line 2  
Manufacturer's CitySamutprakarn  
Manufacturer Province/State  
Manufacturer Country/AreaThailand  
Product Code53IG01  
FDA Product DescriptionDENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)  
Refusal Date23-May-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx 277-0133750-6/6/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
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).  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
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