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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 175-2241160-6/1/1

Manufacturer FEI3008978270
Manufacturer NameHerbolaris Internacional, S.A. De C.V.  
Manufacturer Address line 1Los Robles  
Manufacturer Address line 2  
Manufacturer's CityZapopan  
Manufacturer Province/StateJal  
Manufacturer Country/AreaMexico  
Product Code53JK01  
Importer's Product DescriptionLIPO GRASS GEL  
Refusal Date30-Mar-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx 175-2241160-6/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.