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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 112-3934613-3/1/1/C


Manufacturer FEI3004077415
Manufacturer NameEbos Group  
Manufacturer Address line 1249-243 Bush Road, Albany  
Manufacturer Address line 2  
Manufacturer's CityAuckland  
Manufacturer Province/State  
Manufacturer Country/AreaNew Zealand  
Product Code53LC99  
FDA Product DescriptionOTHER SKIN CARE PREPARATIONS, N.E.C.  
Refusal Date31-Aug-2004  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-3934613-3/1/1/C
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
FALSE   403(a)(1), 801(a)(3); MISBRANDING   The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular [Misbranded, Section 403 (a)(1)].  
LACKS N/C   502(b)(2), 801(a)(3); MISBRANDING   The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.  
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