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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 E7E-1029701-3/2/44


Manufacturer FEI3008878813
Manufacturer NameSESDERMA SL  
Manufacturer Address line 1Pol. Industrial Rafelbunol  
Manufacturer Address line 2Calle Massamagrell 5  
Manufacturer's CityRafelbu┬┐ol  
Manufacturer Province/StateValencia  
Manufacturer Country/AreaSpain  
Product Code53LD01  
FDA Product DescriptionCLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)  
Refusal Date04-Mar-2013  
FDA DistrictFLA-DO  
Entry/doc/line/sfx E7E-1029701-3/2/44
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
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