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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 G01-0347883-3/2/2

Manufacturer FEI3004661547
Manufacturer NameCentral Botanica del Nayar, S.A. de C.V.  
Manufacturer Address line 1Av. Juarez No. 1640-B Col. Obrera  
Manufacturer Address line 2  
Manufacturer's CityEnsenada  
Manufacturer Province/StateMX-BCN  
Manufacturer Country/AreaMexico  
Product Code53ED99  
Importer's Product DescriptionCOMPHOR HAIR OIL  
Refusal Date05-Oct-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx G01-0347883-3/2/2
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.