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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-0067493-2/10/1

Manufacturer FEI3004684605
Manufacturer NameUnilever de Mexico, S. de R.L de C.V  
Manufacturer Address line 1Temascalapa No 2  
Manufacturer Address line 2Col. Rancho Sto. Domingo  
Manufacturer's CityTultitlan  
Manufacturer Province/StateMx-Mex  
Manufacturer Country/AreaMexico  
Product Code53JI02  
Refusal Date06-Apr-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx BVK-0067493-2/10/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NO ENGLISH   502(c); 801(a)(3) ;MISBRANDING   Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.