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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 AMG-0094417-7/2/5

Manufacturer FEI3002651737
Manufacturer NameCeras Especiales Martinez De San Vicente S.A.  
Manufacturer Address line 1Eneergia 19 8940 Cornella De Llobregat  
Manufacturer Address line 2  
Manufacturer's CityBarcelona  
Manufacturer Province/State  
Manufacturer Country/AreaSpain  
Product Code53LK99  
Refusal Date29-Apr-2013  
FDA DistrictFLA-DO  
Entry/doc/line/sfx AMG-0094417-7/2/5
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
FRNMFGREG   510(i); 801(o)   The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.  
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).