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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-0020282-9/14/1

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-0020282-9/14/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
DIRSEXMPT   502(f)(1), 801(a)(3); MISBRANDING   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use. [Misbranded, Section 502(f)(1)]  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.