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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 JN4-0067369-3/1/12

Manufacturer FEI3008615179
Manufacturer NameShuyis Paris  
Manufacturer Address line 167 Avenue Du Marechal Joffre  
Manufacturer Address line 2  
Manufacturer's CityNanterre  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53LD03  
Importer's Product DescriptionANTI TREATMENT CONCENTRATE  
Refusal Date05-Feb-2013  
FDA DistrictLOS-DO  
Entry/doc/line/sfx JN4-0067369-3/1/12
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
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).