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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 BGK-0387652-2/71/1/E

Manufacturer FEI3009433601
Manufacturer NameAl Shaikh Enterprises  
Manufacturer Address line 1V-E-2/6 First Floor Paposh Nagar  
Manufacturer Address line 2Nazimabad  
Manufacturer's CityKarachi  
Manufacturer Province/StateSindh  
Manufacturer Country/AreaPakistan  
Product Code53JY01  
Importer's Product DescriptionSOAP, 115GX72: 10 CASES  
Refusal Date20-Apr-2012  
FDA DistrictDET-DO  
Entry/doc/line/sfx BGK-0387652-2/71/1/E
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
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).  
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.