Archive for January 2026
2025 FDA 483 Review: Why Combination Products Are Disproportionately at Risk
Combination products sit at the intersection of drug CGMPs, device QSR/QSMR, and Part 4 integration requirements. FDA 483 data across both sectors show that organizations continue to manage these requirements in parallel rather than within an integrated quality system, a structural weakness that QSMR will further expose. MEDICAL DEVICES:2025 FDA 483 OBSERVATIONS DESCRIPTION Frequency Lack…
Read MoreFrom Exception to Action: Risk-Based Issue Elevation
Under FDA’s Quality Management System Regulation (QMSR), exception handling is no longer about closing deviations—it is about demonstrating risk-based thinking across the product lifecycle. This expectation applies equally to pharmaceuticals, medical devices, and combination products, where disconnected investigations often delay CAPA or trigger avoidable field actions. The differentiator is how exceptions are understood and elevated.…
Read More