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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 144-4133210-5/20/1

Manufacturer FEI3005805174
Manufacturer NameYiwu Tonsen Imp & Export Co., Ltd.  
Manufacturer Address line 1Rm 401 Unit 2 Bldg 56  
Manufacturer Address line 2Yongshen Area  
Manufacturer's CityYiwu  
Manufacturer Province/StateZhejiang  
Manufacturer Country/AreaChina  
Product Code76EFW  
FDA Product DescriptionTOOTHBRUSH, MANUAL  
Refusal Date16-May-2007  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 144-4133210-5/20/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NO ENGLISH   502(c); 801(a)(3);Misbranding   Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)  
REGISTERED   502(o), 801(a)(3); MISBRANDING   It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).