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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 MC2-6282005-3/1/1

Manufacturer FEI3009173022
Manufacturer NameBeijing Huaren Health Science & Technology Developing Co Ltd  
Manufacturer Address line 1Room No 45 2205 Xizhi  
Manufacturer Address line 2  
Manufacturer's CityMiyunxian  
Manufacturer Province/StateBeijingshi  
Manufacturer Country/AreaChina  
Product Code90KPY  
Refusal Date03-Nov-2011  
FDA DistrictFLA-DO  
Entry/doc/line/sfx MC2-6282005-3/1/1
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).