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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 EH5-0027415-2/10/1


Manufacturer FEI3003788476
Manufacturer NameFarmland Processing And Manufacturing Corp  
Manufacturer Address line 12020 Arpilleda St  
Manufacturer Address line 2  
Manufacturer's CityMakati City  
Manufacturer Province/State  
Manufacturer Country/AreaPhilippines  
Product Code16YCI17  
Importer's Product DescriptionCRAB FAT  
Refusal Date31-Dec-2003  
FDA DistrictSEA-DO  
Entry/doc/line/sfx EH5-0027415-2/10/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
LIST INGRE   403(i)(2), 801(a)(3); MISBRANDING   It appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient.  
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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