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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 UPS-5119764-4/1/1/B


Manufacturer FEI3008540451
Manufacturer NameEdit Wholesale  
Manufacturer Address line 1Unit 4 Concord Business Centre  
Manufacturer Address line 2Concord Road Acton  
Manufacturer's CityLondon  
Manufacturer Province/State  
Manufacturer Country/AreaUnited Kingdom  
Product Code53YY99  
Importer's Product DescriptionCOSMETIC NOVELTY CONTACT LENSES  
Refusal Date22-Feb-2012  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-5119764-4/1/1/B
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.  
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