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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 K80-1016408-6/13/2


Manufacturer FEI3004259394
Manufacturer NameThe Himalaya Drug Company  
Manufacturer Address line 1Makali  
Manufacturer Address line 2  
Manufacturer's CityBangalore  
Manufacturer Province/StateIN-KA  
Manufacturer Country/AreaIndia  
Product Code53LD03  
FDA Product DescriptionFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)  
Refusal Date19-Nov-2012  
FDA DistrictSAN-DO  
Entry/doc/line/sfx K80-1016408-6/13/2
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).  
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