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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 788-0312980-5/1/16


Manufacturer FEI3003667459
Manufacturer NameIstituto Ganassiini  
Manufacturer Address line 116 Via Gaggia  
Manufacturer Address line 2  
Manufacturer's CityMilano  
Manufacturer Province/StateMI  
Manufacturer Country/AreaItaly  
Product Code53SA13  
FDA Product DescriptionSUNTAN PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OVINE)  
Refusal Date05-Mar-2012  
FDA DistrictBLT-DO  
Entry/doc/line/sfx 788-0312980-5/1/16
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).  
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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