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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 BJG-0020282-9/11/1

Manufacturer FEI3006496581
Manufacturer NameProactive Internacional, S.A de C.V  
Manufacturer Address line 1Simon Bolivar 1561-C  
Manufacturer Address line 2Col. Mitras Centro  
Manufacturer's CityMonterrey  
Manufacturer Province/StateMX-NLE  
Manufacturer Country/AreaMexico  
Product Code53ED06  
Refusal Date23-Apr-2013  
FDA DistrictSWI-DO  
Entry/doc/line/sfx BJG-0020282-9/11/1
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).  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.