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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 336-5456865-2/3/1

Manufacturer FEI3007262486
Manufacturer NameBurt's Bees Inc.  
Manufacturer Address line 1900 Aviation Pkwy  
Manufacturer Address line 2  
Manufacturer's CityMorrisville  
Manufacturer Province/StateNC  
Manufacturer Country/AreaUnited States  
Product Code53AC02  
Importer's Product DescriptionBABY BEE DIAPER OINTMENT 0.75 OZ  
Refusal Date13-Sep-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx 336-5456865-2/3/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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).