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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 BVK-0082488-3/13/1/A


Manufacturer FEI1000300384
Manufacturer NameColgate Palmolive SA de CV  
Manufacturer Address line 1Presa De La Angostura 225 P 3  
Manufacturer Address line 2Carretera Mexico-Toluca Km 15.5  
Manufacturer's CityMexico City  
Manufacturer Province/State  
Manufacturer Country/AreaMexico  
Product Code53EY06  
Importer's Product DescriptionCAPRICE HAIR SHMAPOOS 800 ML  
Refusal Date12-Apr-2013  
FDA DistrictSWI-DO  
Entry/doc/line/sfx BVK-0082488-3/13/1/A
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
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