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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 793-0600752-1/4/1


Manufacturer FEI3004942805
Manufacturer NameDerval  
Manufacturer Address line 1Rue De Nants  
Manufacturer Address line 2  
Manufacturer's CityDerval  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code09CYF13  
Importer's Product Description1092 CTNS WHIPPING CREAM FOR EXPORT ONLY FOR SHIP PROVISION ONLY  
Refusal Date11-Dec-2006  
FDA DistrictFLA-DO  
Entry/doc/line/sfx 793-0600752-1/4/1
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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