FDA Cites DanChem For Blending Failed Ingredient Lots With Other Batches
This article was originally published in The Pink Sheet Daily
Executive Summary
Warning letter follows DanChem's inadequate response to a "Form 483" report identifying "significant violations" of cGMPs, including lots "contaminated with physical filth." DanChem's present manufacturing system does not provide adequate protection for the product during processing, FDA says.