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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 FC7-0110993-4/8/1


Manufacturer FEI3008339118
Manufacturer NameHuynh Vu  
Manufacturer Address line 1No 27/40/158 Huynh Tinh Cua Strward 8  
Manufacturer Address line 2  
Manufacturer's CityHo Chi Minh City  
Manufacturer Province/State  
Manufacturer Country/AreaVietnam  
Product Code31KGY99  
FDA Product DescriptionTEA, N.E.C.  
Refusal Date22-Jul-2010  
FDA DistrictMIN-DO  
Entry/doc/line/sfx FC7-0110993-4/8/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
LACKS FIRM   403(e)(1), 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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor [Misbranded, Section 403 (e)(1)].  
LACKS N/C   403(e)(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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act [Misbranded, Section 403 (e)(2)].  
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)]."  
NUTRIT LBL   403(q); 801(a)(3); Misbranding   The article appears to be misbranded in that the label or labeling fails to bear the required nutrition information.  
USUAL NAME   403(i)(1), 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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be [Misbranded, Section 403(i)(1)].  
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