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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 XXX-0133010-0/1/2


Manufacturer FEI6353
Manufacturer NameRymco Ltda  
Manufacturer Address line 1Calle 80 No. 78b-51  
Manufacturer Address line 2  
Manufacturer's CityBarranquilla  
Manufacturer Province/State  
Manufacturer Country/AreaColombia  
Product Code80MEG  
Importer's Product DescriptionMEDICINES  
Refusal Date06-Dec-2005  
FDA DistrictFLA-DO  
Entry/doc/line/sfx XXX-0133010-0/1/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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).  
RXPERSONAL   502(a), 502(f)(1), 801(a)(3), MISBRANDING   The article appears to be a device which requires a prescription from your doctor.  
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