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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 JN4-0064408-2/1/3

Manufacturer FEI3004269797
Manufacturer NameXiamen Yinlu Foods Co., Ltd.  
Manufacturer Address line 1Yinlu High-tech Zone, Xiangan District,  
Manufacturer Address line 2  
Manufacturer's CityXiamen  
Manufacturer Province/StateCN-35  
Manufacturer Country/AreaChina  
Product Code29YGT99  
Importer's Product DescriptionWONG LO KAT HERBAL TEA DRINKS  
Refusal Date02-Nov-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx JN4-0064408-2/1/3
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
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.