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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 F23-9055347-7/1/1/B

Manufacturer FEI3008978601
Manufacturer NameConcorde Marketing Pte Ltd  
Manufacturer Address line 1No 1 Coleman Street  
Manufacturer Address line 2  
Manufacturer's CitySingapore  
Manufacturer Province/State  
Manufacturer Country/AreaSingapore  
Product Code53AY02  
Importer's Product DescriptionLOTION  
Refusal Date20-Jan-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx F23-9055347-7/1/1/B
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).