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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 112-9799163-3/2/1


Manufacturer FEI3007958061
Manufacturer NameUsana Australia  
Manufacturer Address line 13 Hudson Avenue Castle Hill  
Manufacturer Address line 2  
Manufacturer's CityCastle Hill  
Manufacturer Province/StateNew South Wales  
Manufacturer Country/AreaAustralia  
Product Code53UC12  
FDA Product DescriptionSKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS)  
Refusal Date27-Oct-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-9799163-3/2/1
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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