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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 201-9212282-7/1/1


Manufacturer FEI3003910487
Manufacturer NameMerz Pharma Gmbh  
Manufacturer Address line 1Ludwigstr 22  
Manufacturer Address line 2  
Manufacturer's CityReinheim  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code53LY02  
Importer's Product DescriptionMEDERMA  
Refusal Date12-Apr-2013  
FDA DistrictATL-DO  
Entry/doc/line/sfx 201-9212282-7/1/1
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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