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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 AEK-0279840-9/1/1


Manufacturer FEI3009538620
Manufacturer NameTecser Laboratorios Ltda  
Manufacturer Address line 1Ci 23 B 104 B 43/59  
Manufacturer Address line 2  
Manufacturer's CityBogota  
Manufacturer Province/State  
Manufacturer Country/AreaColombia  
Product Code53LC06  
Importer's Product DescriptionANTI TACHER PROPOLLIS WAX NATURAL FACE CREAM  
Refusal Date04-Mar-2013  
FDA DistrictFLA-DO  
Entry/doc/line/sfx AEK-0279840-9/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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