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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 251-1472236-3/3/1/B

Manufacturer FEI3008357396
Manufacturer NameEl Captain Co. (Cap Pharm)  
Manufacturer Address line 1Industrial Area - El Obour City  
Manufacturer Address line 2  
Manufacturer's CityCairy  
Manufacturer Province/State  
Manufacturer Country/AreaEgypt  
Product Code53ED06  
Refusal Date09-May-2012  
FDA DistrictATL-DO  
Entry/doc/line/sfx 251-1472236-3/3/1/B
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.  
NO ENGLISH   403(f), 801(a)(3); MISBRANDING   Required label or labeling appears to not be in English per 21 CFR 101.15(c).