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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/A

Manufacturer FEI3008978270
Manufacturer NameHerbolaris Internacional, S.A. De C.V.  
Manufacturer Address line 1Los Robles 122  
Manufacturer Address line 2Fraccionamiento Los Robles  
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/A
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.