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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 WX6-0015156-6/9/1


Manufacturer FEI3004271362
Manufacturer Name"Biona-plus" Ltd  
Manufacturer Address line 19, Tsiolkovskogo street  
Manufacturer Address line 2  
Manufacturer's CityChernigov  
Manufacturer Province/StateUA-74  
Manufacturer Country/AreaUkraine  
Product Code40DCT99  
FDA Product DescriptionVEGETABLES, N.E.C. (BABY)  
Refusal Date05-Aug-2004  
FDA DistrictSAN-DO  
Entry/doc/line/sfx WX6-0015156-6/9/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
INCONSPICU   403(f), 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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)) [Misbranded, Section 403 (f)].  
NEEDS FCE   402(a)(4), 801(a)(3); ADULTERATION   It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).  
NO PROCESS   402(a)(4), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.  
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.  
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