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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 U72-0519099-5/9/1

Manufacturer FEI3004153308
Manufacturer NameTheramed Ltd  
Manufacturer Address line 13 Churchwood Lodge Rd  
Manufacturer Address line 2  
Manufacturer's CityHalesworth  
Manufacturer Province/State  
Manufacturer Country/AreaUnited Kingdom  
Product Code53JY01  
Importer's Product DescriptionLLCE BI SOAP  
Refusal Date29-Aug-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx U72-0519099-5/9/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
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).