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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 112-7456058-5/9/1/I


Manufacturer FEI3004386420
Manufacturer NameDabur International Limited  
Manufacturer Address line 1Between R/A 6&7 Jebel Ali Free Zone  
Manufacturer Address line 2  
Manufacturer's CityDubai  
Manufacturer Province/StateAE-NOTA  
Manufacturer Country/AreaUnited Arab Emirates  
Product Code53FC06  
FDA Product DescriptionHAIR LIGHTENERS, WITH COLOR (HAIR COLORING PREPARATIONS)  
Refusal Date12-Jun-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-7456058-5/9/1/I
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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).  
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.  
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