The QMSR is Here: FDA’s First QMSR Warning Letters August 12, 2026 By Allyson B. Mullen & Esther Petrikovsky —

https://www.thefdalawblog.com/2026/08/the-qmsr-is-here-fdas-first-qmsr-warning-letters/?utm_source=rss&utm_medium=rss&utm_campaign=the-qmsr-is-here-fdas-first-qmsr-warning-letters Last week FDA publicly posted the first Quality Management System Regulation (QMSR) Warning Letter and this week it posted the second. The QMSR went into effect in February of this year. For months, we have seen the top 483 citations shift in FDA’s inspection database from those under the Quality System Regulation (QSR) to the QMSR. The most significant change from the QSR to the QMSR is the QMSR’s focus on risk management, as discussed in our prior post (here). It has, therefore, been of little surprise to see risk-management related 483 citations rise to being the top citation—greater than 20% of all 483 citations—when you combine process and record-related observations under ISO 13485 clause 7.1.