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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 AEK-8479082-9/1/1

Manufacturer FEI3006813729
Manufacturer Name2plus Electronic I  
Manufacturer Address line 13 Industry Zone  
Manufacturer Address line 2  
Manufacturer's CityZhongshan Cit  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code95RES  
Refusal Date01-Nov-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx AEK-8479082-9/1/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
FAILS STD   501(e), 801(a)(3); ADULTERATION   The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.  
INCONSPICU   502(c), 801(a)(3); MISBRANDING   Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.  
WARNINGS   502(f)(2), 801(a)(3); MISBRANDING   It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.