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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 D76-1102737-7/1/1

Manufacturer FEI3004604396
Manufacturer NameCe Nedra Pvt Ltd  
Manufacturer Address line 1Tanamera Estate  
Manufacturer Address line 2  
Manufacturer's CityIbbawala Weligama  
Manufacturer Province/State  
Manufacturer Country/AreaSri Lanka  
Product Code23DEE05  
FDA Product DescriptionCOCONUT, PASTE  
Refusal Date18-Dec-2006  
FDA DistrictSWI-DO  
Entry/doc/line/sfx D76-1102737-7/1/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NONRSP-PRC   402(a)(4), 801(a)(3); ADULTERATION   The article appears to have been prepared or packed under insanitary conditions whereby it may have been rendered injurious to health due to inadequate processing in that the scheduled process filed by the manufacturer pursuant to 21 CFR 108.35(c)(2) appears to be inadequate to protect the public health.