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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-8490277-0/1/1


Manufacturer FEI3007056035
Manufacturer NameShanghai Forcaza G  
Manufacturer Address line 1578 Tianbao Rd  
Manufacturer Address line 2  
Manufacturer's CityShanghai  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code86LPL  
FDA Product DescriptionLENSES, SOFT CONTACT, DAILY WEAR  
Refusal Date01-Nov-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx AEK-8490277-0/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
DIRECTIONS   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use.  
DV NAME   502(e)(2); 801(a)(3); Misbranding   The article appears to be a device and its labeling fails to bear the proprietary or established name.  
FALSE   502(a), 801(a)(3); MISBRANDING   The labeling for this article appears to be false or misleading  
LACKS FIRM   502(b)(1), 801(a)(3); MISBRANDING   The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.  
NO 510(K)   801(a)(3); 502(o) Misbranding   It appears that a notice or other information respecting the device was not provided to FDA, as required by Section 510(k) and the device was not found to be substantially equivalent to a predicate device.  
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).  
REGISTERED   502(o), 801(a)(3); MISBRANDING   It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).  
RX DEVICE   502(a),(f)(1), 801(a)(3); MISBRANDING   The article appears to be a prescription device without a prescription device legend as required by 21 CFR 801.109.  
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