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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 175-2241531-8/1/1/B

Manufacturer FEI3010178058
Manufacturer NameHerbolaris Internacional  
Manufacturer Address line 1Los Robles 122  
Manufacturer Address line 2  
Manufacturer's CityZapopan  
Manufacturer Province/StateJal  
Manufacturer Country/AreaMexico  
Product Code53ED06  
Refusal Date14-Mar-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx 175-2241531-8/1/1/B
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NO ENGLISH   403(f), 801(a)(3); MISBRANDING   Required label or labeling appears to not be in English per 21 CFR 101.15(c).  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.