Supplier Quality

If you've spent any time reviewing FDA warning letters, you've probably noticed a pattern: supplier-related issues show up everywhere. Incoming materials that don't meet specifications. Components with undisclosed changes. Test results from unqualified laboratories. Suppliers who can't demonstrate their own quality systems are adequate. The FDA's FY2024 Report on the State of Pharmaceutical Quality drove this point home. Over the past five years, 72% of regulatory actions aga