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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 SQ4-0083300-1/1/1

Manufacturer FEI3008496886
Manufacturer NameHongkong Everrise  
Manufacturer Address line 1401 C Tiandi Garden Taiwan St  
Manufacturer Address line 2  
Manufacturer's CityXiamen  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code53LY03  
Refusal Date06-Jul-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx SQ4-0083300-1/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
FRNMFGREG   502(o), 801(a)(3); MISBRANDING   The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&CA. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act. [Misbranding, Section 502(o), 801(a)(3)].  
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.