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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 J34-0060568-2/14/1


Manufacturer FEI3004886375
Manufacturer NameUnilever Thai Trading Limited  
Manufacturer Address line 118 SCB Park Plaza Tower 1  
Manufacturer Address line 2Ratchadapisek Road  
Manufacturer's CityBangkok  
Manufacturer Province/StateLadyao, Jatujak  
Manufacturer Country/AreaThailand  
Product Code66PBR99  
FDA Product DescriptionULTRAVIOLET SCREEN N.E.C.  
Refusal Date29-Sep-2010  
FDA DistrictNYK-DO  
Entry/doc/line/sfx J34-0060568-2/14/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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. 201.15(c)(1).  
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).  
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