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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 221-2101031-2/10/1

Manufacturer FEI3004266993
Manufacturer NameMacro Erma Exporters Inc.  
Manufacturer Address line 11485 115 North Bay Blvd. Navotas  
Manufacturer Address line 2  
Manufacturer's CityMetro Manila  
Manufacturer Province/StateNational Capital Region  
Manufacturer Country/AreaPhilippines  
Product Code16YCT03  
Refusal Date29-Dec-2003  
FDA DistrictSAN-DO  
Entry/doc/line/sfx 221-2101031-2/10/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
FALSE   403(a)(1), 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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular [Misbranded, Section 403 (a)(1)].  
FILTHY   402(a)(3), 801(a)(3); ADULTERATION   The article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.