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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 BLW-0544309-4/7/1

Manufacturer FEI3008811202
Manufacturer NameEng Kah Enterprise (Kl) Sdn Bhd  
Manufacturer Address line 1Lot 152, Jalan Permata 1, Arab Malaysian  
Manufacturer Address line 2  
Manufacturer's CityNilai  
Manufacturer Province/State  
Manufacturer Country/AreaMalaysia  
Product Code53LY01  
Importer's Product DescriptionNUTRI RICH APRICOT FACIAL SCRUB  
Refusal Date10-Oct-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx BLW-0544309-4/7/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
COLOR LBLG   602(e), 801(a)(3); MISBRANDING   The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.  
COSM COLOR   601(e), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).