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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 BLN-0050820-7/1/4

Manufacturer FEI3007504598
Manufacturer NameCADBURY ADAMS MEXICO, S DE R.L. DE C.V.  
Manufacturer Address line 1AV SANTA FE NO 485  
Manufacturer Address line 2COL CRUZ MANCA  
Manufacturer Province/StateMX-DIF  
Manufacturer Country/AreaMexico  
Product Code66FBY99  
FDA Product DescriptionSUPPRESSANT N.E.C.  
Refusal Date10-Sep-2010  
FDA DistrictSWI-DO  
Entry/doc/line/sfx BLN-0050820-7/1/4
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
INCONSPICU   502(c), 801(a)(3); MISBRANDING   Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.  
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.