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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 BYA-0121120-0/27/1


Manufacturer FEI3004268841
Manufacturer NameConsolidated Business Systems (Pvt.) Ltd.  
Manufacturer Address line 1184/2 , KAOLIN REFINERY ROAD  
Manufacturer Address line 2WERAHERA  
Manufacturer's CityBoralesgamuwa  
Manufacturer Province/StateColombo  
Manufacturer Country/AreaSri Lanka  
Product Code53FD99  
Importer's Product DescriptionKUMARIKA HAIR OIL  
Refusal Date29-Jun-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx BYA-0121120-0/27/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COLOR LBLG   403(k), 801(a)(3); MISBRANDING   The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.  
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.  
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.  
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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