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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 508-0339274-0/2/1

Manufacturer FEI3009386482
Manufacturer NameJothoor For Natural Products  
Manufacturer Address line 1Sahab Altajamouat Ind. Esteat,Building B  
Manufacturer Address line 2  
Manufacturer's CityAmmanjo  
Manufacturer Province/State  
Manufacturer Country/AreaJordan  
Product Code53LD09  
Importer's Product DescriptionDR. NATURAL ONITAL CREMS 30G.  
Refusal Date29-Mar-2012  
FDA DistrictSJN-DO  
Entry/doc/line/sfx 508-0339274-0/2/1
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.