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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   Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.  
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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