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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 MH9-2006403-6/1/1

Manufacturer FEI3009826976
Manufacturer NameBuy Asian Solutions Ltda  
Manufacturer Address line 1831 Xinzha Road  
Manufacturer Address line 2  
Manufacturer's CityShanghai  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code53JD01  
Importer's Product DescriptionHAND SANITIZER  
Refusal Date19-Nov-2012  
FDA DistrictFLA-DO  
Entry/doc/line/sfx MH9-2006403-6/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
FRNMFGREG   510(i); 801(o)   The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.  
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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