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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 231-2438190-0/1/2/F

Manufacturer FEI3008737883
Manufacturer NameHainan Jiahua Marine Bio-Pharmaceutical Group Ltd.  
Manufacturer Address line 1Wenqing Avenue  
Manufacturer Address line 2Qinglan Development Zone  
Manufacturer's CityWenchang City  
Manufacturer Province/StateHainansheng  
Manufacturer Country/AreaChina  
Product Code53UD12  
Importer's Product DescriptionFACIAL SERUM  
Refusal Date26-Oct-2011  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 231-2438190-0/1/2/F
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.