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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 E10-0207197-8/4/1


Manufacturer FEI3007132654
Manufacturer NameParamount Agencies  
Manufacturer Address line 1Sadar Center 322 Serai Road  
Manufacturer Address line 2  
Manufacturer's CityKarachi  
Manufacturer Province/State  
Manufacturer Country/AreaPakistan  
Product Code53IH01  
FDA Product DescriptionDENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)  
Refusal Date20-Dec-2011  
FDA DistrictATL-DO  
Entry/doc/line/sfx E10-0207197-8/4/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
LIST INGRE   403(i)(2), 801(a)(3); MISBRANDING   The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. [Misbranded, Section 403(i)(2)]."  
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