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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 BKA-0111661-8/9/1

Manufacturer FEI3001203941
Manufacturer NamePeter Hallifax Ltd  
Manufacturer Address line 152 Essex Street  
Manufacturer Address line 2  
Manufacturer's CityChristchurch  
Manufacturer Province/StateFN  
Manufacturer Country/AreaNew Zealand  
Product Code53UC99  
Importer's Product DescriptionLANOLIN SKIN CARE PRODUCTS  
Refusal Date07-Dec-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx BKA-0111661-8/9/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
COSM COLOR   601(e), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.