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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 231-3383046-7/1/2

Manufacturer FEI3003354641
Manufacturer NameSavini Tartufi s.r.l.  
Manufacturer Address line 1Piazza C. D'Ascanio  
Manufacturer Address line 2  
Manufacturer's CityPalala Loc. Forcoli (Pisa)  
Manufacturer Province/StatePISA  
Manufacturer Country/AreaItaly  
Product Code28KCT99  
Refusal Date10-Sep-2013  
FDA DistrictNWE-DO  
Entry/doc/line/sfx 231-3383046-7/1/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
LACKS N/C   403(e)(2), 801(a)(3); MISBRANDING   The food is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regulations.  
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.  
USUAL NAME   403(i)(1), 801(a)(3); MISBRANDING   It appears that the label does not bear the common or usual name of the food.