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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 H87-0196178-6/2/1


Manufacturer FEI3003898365
Manufacturer NameCentro Botanico Azteca SA  
Manufacturer Address line 1San Simon #24-A Esq. Limon  
Manufacturer Address line 2Col. Merced Centro, Deleg V. Carranza  
Manufacturer's CityMexico City  
Manufacturer Province/StateFederal District  
Manufacturer Country/AreaMexico  
Product Code53LD99  
FDA Product DescriptionOTHER SKIN CARE PREPARATIONS, N.E.C.  
Refusal Date16-May-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx H87-0196178-6/2/1
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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