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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 EVH-0002693-6/1/1


Manufacturer FEI3004258502
Manufacturer Namehubei sangang food company ltd  
Manufacturer Address line 125 Hongshan Street  
Manufacturer Address line 2Sangliging Town  
Manufacturer's Citysuizhou  
Manufacturer Province/StateCN-13  
Manufacturer Country/AreaChina  
Product Code25PGH01  
FDA Product DescriptionMUSHROOM, COMMON (AGARICUS BISPORUS), WHOLE (BUTTON) (FUNGI)  
Refusal Date25-Nov-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx EVH-0002693-6/1/1
FDA Sample AnalysisYes  
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)]."  
SULFITELBL   403(a)(1), 801(a)(3) ;MISBRANDING   The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because 1) it appears to contain sulfites but the label fails to declare the presence of sulfites, a fact material to sulfite-sensitive individuals who must avoid the ingredient due to potential health consequences from its consumption [Misbranded, 403(a)(1)], and 2) it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient [Misbranded, 403(i)(2)].  
TRANSFAT   403(q), 801(a)(3) ;MISBRANDING   The product is misbranded under Section 403(q) because the nutrition label does not provide all of the information required by 21 CFR 101.9(c); specifically, the label does not bear the amount of trans fat [21 CFR 101.9(c)(2)(ii)].  
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