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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 235-1059416-3/2/1

Manufacturer FEI3008993977
Manufacturer NameGaline Industrial Co Ltd  
Manufacturer Address line 1No 144 Shiyizhi Cuo Shuishangtonwship  
Manufacturer Address line 2  
Manufacturer's CityChiayi  
Manufacturer Province/State  
Manufacturer Country/AreaTaiwan  
Product Code53IG01  
Importer's Product DescriptionTOOTHPASTE WITH GREEN TEA EXTRACT  
Refusal Date19-Jan-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx 235-1059416-3/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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.  
UNSAFE COL   501(a)(4)(B), 801(a)(3); ADULTERATION   The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).