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Foreign Material Specifications

  • 1.  Foreign Material Specifications

    Posted 08-Sep-2011 11:22

    We are a bulk API company interested in validating that our foreign material specifications are current with industry and agency expectations.  I realize that companies shouldn't share their specs on this forum but does anyone know of an FDA or EU standard or position statement?  I have US FDA CPG Sec. 555.425 Foods, Adulteration Involving Hard or Sharp Foreign Objects, FSIS 1995 data on bone particle size safety,  and FDA Health Hazard Evaluation Board data.  However, I was looking for standards or opinions applicable to API's. 
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    Lisa Fischer
    United States
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