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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 M21-0744712-2/1/1


Manufacturer FEI3008367099
Manufacturer NameShanghai Trifecta Pharma Ltd.  
Manufacturer Address line 1Yueda Inter.Tower 1118 Changshou Rd  
Manufacturer Address line 2  
Manufacturer's CityShanghai  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code56BAA05  
Importer's Product DescriptionAMPICILLIN "FOR EXPORT ONLY" PLEASE REFUSE THE CARGO  
Refusal Date23-Nov-2011  
FDA DistrictFLA-DO  
Entry/doc/line/sfx M21-0744712-2/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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