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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 551-1975916-0/19/1


Manufacturer FEI1000282628
Manufacturer NameAgros Trading Co.  
Manufacturer Address line 1613 Chalubinkiego 8  
Manufacturer Address line 2  
Manufacturer's CityWarszawa  
Manufacturer Province/State  
Manufacturer Country/AreaPoland  
Product Code25SGE01  
FDA Product DescriptionMUSHROOM, COMMON (AGARICUS BISPORUS), FUNGI PRODUCTS, N.E.C.  
Refusal Date20-May-2002  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 551-1975916-0/19/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
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.  
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