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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 H87-0198854-0/7/1

Manufacturer FEI3003097030
Manufacturer NameLaboratorio Bremer, S.A. De C.V.  
Manufacturer Address line 1Cd. Industrial Mitras Omicron 8116  
Manufacturer Address line 2  
Manufacturer's CityMonterrey,Nuevo Leon  
Manufacturer Province/State  
Manufacturer Country/AreaMexico  
Product Code53LC99  
Importer's Product DescriptionOINTMENT ARNICA DE LA ABUELA  
Refusal Date14-Nov-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx H87-0198854-0/7/1
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.  
LABELING   Section 4(a); 801(a)(3) Misbranding   The article appears in violation of FPLA because of its placement, form and/or contents statement.