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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 112-4568522-2/1/1


Manufacturer FEI3005068563
Manufacturer NameNutraland Limited  
Manufacturer Address line 12404, Office Building C  
Manufacturer Address line 2No. 70, Cao Bao Lu  
Manufacturer's CityShanghai  
Manufacturer Province/StateCN-31  
Manufacturer Country/AreaChina  
Product Code65JAR31  
Importer's Product Description876391527591 PROGESTERON  
Refusal Date25-Nov-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-4568522-2/1/1
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).  
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