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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 E84-0044713-0/1/1


Manufacturer FEI3008651975
Manufacturer NameUnilever Centroamerica  
Manufacturer Address line 1San Antonio de Belen Heredia. Del Cruce  
Manufacturer Address line 2400 Mts Oeste y 800 Mts Norte  
Manufacturer's CitySan Jose  
Manufacturer Province/StateSan Jose  
Manufacturer Country/AreaCosta Rica  
Product Code27YCI06  
FDA Product DescriptionPEPPER SAUCE (HOT, MILD, ETC.)  
Refusal Date08-Dec-2006  
FDA DistrictFLA-DO  
Entry/doc/line/sfx E84-0044713-0/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NO ENGLISH   403(f), 801(a)(3); MISBRANDING   Required label or labeling appears to not be in English per 21 CFR 101.15(c).  
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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