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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 EB5-1512745-5/1/1


Manufacturer FEI3009545832
Manufacturer NameUnion-Swiss Pacific  
Manufacturer Address line 18 Middle Road Bardene Extension 32  
Manufacturer Address line 2  
Manufacturer's CityBoksburg  
Manufacturer Province/State  
Manufacturer Country/AreaSouth Africa  
Product Code53LD06  
Importer's Product DescriptionBIO OIL  
Refusal Date12-Oct-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx EB5-1512745-5/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
UNSAFE COL   501(a)(4)(B), 801(a)(3); ADULTERATION   The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).  
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