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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 BOY-0002756-2/1/2/B

Manufacturer FEI3004024835
Manufacturer NameSigma Soap Ltd.  
Manufacturer Address line 1Irwell Vale  
Manufacturer Address line 2  
Manufacturer's CityLancashire  
Manufacturer Province/State  
Manufacturer Country/AreaUnited Kingdom  
Product Code53JK01  
Importer's Product Description412 CTNS OF TOILET SOAP 85 G  
Refusal Date20-Jul-2012  
FDA DistrictFLA-DO  
Entry/doc/line/sfx BOY-0002756-2/1/2/B
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).  
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).