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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-6468888-6/2/1/A

Manufacturer FEI3006146838
Manufacturer NameChiara Ambra Cosmetic & Health Pro.  
Manufacturer Address line 1Auf Der Schulmatt 7/1  
Manufacturer Address line 2  
Manufacturer's CityD-77743 Neuried  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code53CC04  
Importer's Product DescriptionSTEM CELL EYE GEL/NGUYEN, HUNG/DALY CITY, CA  
Refusal Date03-Jul-2012  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-6468888-6/2/1/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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