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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 BVU-0133222-3/9/1

Manufacturer FEI3008318646
Manufacturer NameSewha P And C Inc.  
Manufacturer Address line 1322-1 Eunam-ri Chopyeong-myeon  
Manufacturer Address line 2Jincheon Gun  
Manufacturer's CityChungcheongbuk-do  
Manufacturer Province/State  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53ED06  
Refusal Date18-Apr-2013  
FDA DistrictSEA-DO  
Entry/doc/line/sfx BVU-0133222-3/9/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.