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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 WQ8-9614228-5/2/1/A

Manufacturer FEI3006178968
Manufacturer NameJohnson & Johnson  
Manufacturer Address line 11 Jl Mampang Prapatan Raya  
Manufacturer Address line 2  
Manufacturer's CityJakarta,Indonesia  
Manufacturer Province/State  
Manufacturer Country/AreaIndonesia  
Product Code53AY99  
FDA Product DescriptionOTHER BABY PRODUCTS, N.E.C.  
Refusal Date23-Nov-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx WQ8-9614228-5/2/1/A
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.