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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 D68-0136068-9/2/2

Manufacturer FEI3008486568
Manufacturer NameAustralian Pharmaceutical Mfg.  
Manufacturer Address line 125 Pickering Road  
Manufacturer Address line 2  
Manufacturer's CityMulgrave  
Manufacturer Province/State  
Manufacturer Country/AreaAustralia  
Product Code53LC03  
Refusal Date30-Jul-2012  
FDA DistrictCHI-DO  
Entry/doc/line/sfx D68-0136068-9/2/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
LACKS N/C   502(b)(2), 801(a)(3); MISBRANDING   The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.  
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).  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.