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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 JG3-3105774-9/4/1/A

Manufacturer FEI3004157113
Manufacturer NameGarmol Processed Foods  
Manufacturer Address line 118 Calle Poniente 5 Y 23 Av Sur  
Manufacturer Address line 2  
Manufacturer's CitySan Salvador  
Manufacturer Province/State  
Manufacturer Country/AreaEl Salvador  
Product Code17FEY99  
Importer's Product DescriptionSOUP  
Refusal Date31-Jan-2005  
FDA DistrictATL-DO  
Entry/doc/line/sfx JG3-3105774-9/4/1/A
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
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.