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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 580-2905613-0/2/1


Manufacturer FEI3003681967
Manufacturer NameVitamin Broker  
Manufacturer Address line 1201 Commercial Rd  
Manufacturer Address line 2  
Manufacturer's CitySouth Yarra  
Manufacturer Province/StateVIC  
Manufacturer Country/AreaAustralia  
Product Code54FCF99  
FDA Product DescriptionHERBALS & BOTANICALS (NOT TEAS), N.E.C.  
Refusal Date20-Aug-2002  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 580-2905613-0/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
DIETARYLBL   403(s)(2)(B), 801(a)(3), misbranded   The label/labeling of the dietary supplement fails to identify the product by using the term "dietary supplement".  
LABELING   Section 4(a); 801(a)(3) Misbranding   The article appears in violation of FPLA because of its placement, form and/or contents statement.  
NUTRIT LBL   403(q); 801(a)(3); Misbranding   The article appears to be misbranded in that the label or labeling fails to bear the required nutrition information.  
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