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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 408-1366518-6/1/1


Manufacturer FEI3009784113
Manufacturer NameEarthoil  
Manufacturer Address line 1Langata Link,Langata South Rd,  
Manufacturer Address line 2  
Manufacturer's CityLangata  
Manufacturer Province/State  
Manufacturer Country/AreaKenya  
Product Code53LY99  
FDA Product DescriptionOTHER SKIN CARE PREPARATIONS, N.E.C.  
Refusal Date14-Mar-2013  
FDA DistrictSAN-DO  
Entry/doc/line/sfx 408-1366518-6/1/1
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.  
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).  
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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