Latest FDA Warning Letters Highlight Aseptic Processing Issues
This article was originally published in The Gold Sheet
Executive SummaryA number of recent FDA warning letters focused on GMP issues with aseptic processing, signaling the agency’s continuing concern about contamination prevention.
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Inspection in February and March found GMP violations including failing to thoroughly investigate unexplained batch discrepancies or failures, regardless of whether it already is distributed, are repeats from 2010 problems FDA found at Haw Par Healthcare.