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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 H87-0196111-7/5/1

Manufacturer FEI3004565783
Manufacturer NameLaboratories De Productos Naturales Azeteca S.A. De. C.V.  
Manufacturer Address line 1Rosalio Bustamante No. 72  
Manufacturer Address line 2Col. Santa Martha Acatitla  
Manufacturer's CityMexico City  
Manufacturer Province/State  
Manufacturer Country/AreaMexico  
Product Code53LD06  
Refusal Date15-May-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx H87-0196111-7/5/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
COLOR LBLG   602(e), 801(a)(3); MISBRANDING   The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.  
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.