FDA Just Held Its First QMSR Town Hall. Here's What the Enforcement Data Already Tells Us.
132 Form 483 observations across 52 inspections. 89.4% cite ISO 13485:2016 clauses directly. 50% of inspected firms received risk management observations. The first comprehensive analysis of post-QMSR enforcement data from FDA's public databases, combined with intelligence from the April 1, 2026 Town Hall.
Read the analysis