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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 582-2882561-7/1/1/A

Manufacturer FEI3003446831
Manufacturer NameFludan Fine Chemicals Inc  
Manufacturer Address line 1570 Concession 4  
Manufacturer Address line 2  
Manufacturer's CityVankleek Hill  
Manufacturer Province/StateON  
Manufacturer Country/AreaCanada  
Product Code56ECY22  
Refusal Date14-Nov-2001  
FDA DistrictDET-DO  
Entry/doc/line/sfx 582-2882561-7/1/1/A
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
DIRECTIONS   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use.  
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).