Latest FDA Warning Letters Highlight Aseptic Processing Issues
This article was originally published in The Gold Sheet
Executive Summary
A number of recent FDA warning letters focused on GMP issues with aseptic processing, signaling the agency’s continuing concern about contamination prevention.
You may also be interested in...
Tiger Balm External Analgesic Firm Scratched Again On US GMP Violations
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.
FDA Continues Aggressive Enforcement as Drug GMP Warning Letters Mount
The Obama administration’s FDA continues to deliver on its promise of swift and aggressive enforcement of drug GMP requirements that it pronounced two years ago.
FDA Continues Aggressive Enforcement as Drug GMP Warning Letters Mount
The Obama administration’s FDA continues to deliver on its promise of swift and aggressive enforcement of drug GMP requirements that it pronounced two years ago.