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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 KM6-0122286-2/18/1

Manufacturer FEI3003333240
Manufacturer NameA.Q. & Company  
Manufacturer Address line 110-11 Eidgah M. A. Jinnah Roadg. P. O.  
Manufacturer Address line 2  
Manufacturer's CityKarachi  
Manufacturer Province/State  
Manufacturer Country/AreaPakistan  
Product Code53CK02  
Importer's Product DescriptionHASHMI KAJAL PENCIL  
Refusal Date01-Jun-2012  
FDA DistrictSAN-DO  
Entry/doc/line/sfx KM6-0122286-2/18/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COLOR LBLG   602(e), 801(a)(3); MISBRANDING   The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.  
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).  
COSMETLBLG   5(c)(3)(B); 801(a)(3) Misbranding   It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.  
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