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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 520-0832759-6/1/1/B


Manufacturer FEI3008294423
Manufacturer NameJohnson & Johnson  
Manufacturer Address line 15760 W 96th St  
Manufacturer Address line 2  
Manufacturer's CityLos Angeles  
Manufacturer Province/StateCA  
Manufacturer Country/AreaUnited States  
Product Code53LD03  
Importer's Product DescriptionHAND FACE BODY LOTION  
Refusal Date07-Jan-2013  
FDA DistrictFLA-DO  
Entry/doc/line/sfx 520-0832759-6/1/1/B
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
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