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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  
FDA Product DescriptionSAUCE, SEAFOOD (N.E.C.), FISHERY PRODUCTS, N.E.C.  
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   The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. [Misbranded, Section 403(i)(2)]."  
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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