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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 112-4235655-3/1/1

Manufacturer FEI3007751274
Manufacturer NameSuzhou Amerigen Pharmaceutical  
Manufacturer Address line 1Suzhou Industrial Park  
Manufacturer Address line 2NO. 58 Qunxingyilu; Pingjiangqu  
Manufacturer's CitySuzhou City  
Manufacturer Province/StateJiangsusheng  
Manufacturer Country/AreaChina  
Product Code55RY99  
Refusal Date15-Nov-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-4235655-3/1/1
FDA Sample AnalysisNo  
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.