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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 438-0811922-6/3/1

Manufacturer FEI3010098874
Manufacturer NameAlopecil Corporation, S.R.L.  
Manufacturer Address line 1Autopista 30 de Mayo No. 111  
Manufacturer Address line 2Haina, D.N.  
Manufacturer's CitySanto Domingo  
Manufacturer Province/StateDO-01  
Manufacturer Country/AreaDominican Republic  
Product Code53ED06  
Importer's Product DescriptionSHAMPOO "APRETOL"  
Refusal Date11-Feb-2013  
FDA DistrictSJN-DO  
Entry/doc/line/sfx 438-0811922-6/3/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
LABELING   Section 4(a); 801(a)(3) Misbranding   The article appears in violation of FPLA because of its placement, form and/or contents statement.