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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 112-7228761-1/6/1/A

Manufacturer FEI3003350259
Manufacturer NamePt Mandom Indonesia Tbk  
Manufacturer Address line 1Jl. Yos Sudarso Pass.P.O. Box 1072  
Manufacturer Address line 2  
Manufacturer's CityJakarta  
Manufacturer Province/State  
Manufacturer Country/AreaIndonesia  
Product Code53ED07  
Importer's Product Description496817233220 HAIR OIL  
Refusal Date22-May-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-7228761-1/6/1/A
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
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.