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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 112-7490207-6/3/1/B

Manufacturer FEI3009541792
Manufacturer NameDK Laboratories Sdn Bhd  
Manufacturer Address line 1Plot No 3, Jalan Industry 3  
Manufacturer Address line 2Jelapang Free Trade Zone  
Manufacturer's CityIpoh  
Manufacturer Province/StatePerak  
Manufacturer Country/AreaMalaysia  
Product Code53LC08  
Importer's Product Description793510479679 HERBAL CREAM  
Refusal Date30-May-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-7490207-6/3/1/B
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
COSMETLBLG   5(c)(3)(B); 801(a)(3) Misbranding   It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.