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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 109-0858810-5/2/3


Manufacturer FEI3008742077
Manufacturer NameJohnson-Johnson Indonesia  
Manufacturer Address line 1Jln Wisma Jaya  
Manufacturer Address line 2  
Manufacturer's CityJakarta  
Manufacturer Province/StateJabotabek  
Manufacturer Country/AreaIndonesia  
Product Code53ID02  
FDA Product DescriptionMOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)  
Refusal Date06-Sep-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 109-0858810-5/2/3
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
DIRECTIONS   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use.  
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