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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-6624614-7/4/1/A


Manufacturer FEI3006001251
Manufacturer NameLaboratoires Dematologiques DUCRAY  
Manufacturer Address line 145, place Abel-Gance  
Manufacturer Address line 2  
Manufacturer's CityBoulogne Billancourt  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53ED01  
Importer's Product DescriptionCHRONOSTIM DAY/NIGHT HAIR LOSS TREATMENT 2X50ML  
Refusal Date26-Jul-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx UPS-6624614-7/4/1/A
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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).  
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