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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 J72-0012198-0/1/1/E

Manufacturer FEI3003769105
Manufacturer NameConservas Huertas S.A.  
Manufacturer Address line 1Cervantes 19  
Manufacturer Address line 2  
Manufacturer's CityMalagon (C.Real)  
Manufacturer Province/State  
Manufacturer Country/AreaSpain  
Product Code38YET99  
FDA Product DescriptionSOUP, N.E.C.  
Refusal Date15-Apr-2003  
FDA DistrictFLA-DO  
Entry/doc/line/sfx J72-0012198-0/1/1/E
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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.