FDA official details top observations from QMSR inspections
The top observations identified in Form 483 reports from inspections conducted under the recently implemented Quality Management System Regulation (QMSR) include risk management, outsourcing and purchasing, and complaint handling and feedback.
These insights came from Keisha Thomas, associate director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health’s Office of Product Evaluation and Quality. Additional observations pertain to unique device identifiers and corrective actions.
Thomas shared her key observations at the Food and Drug Law Institute’s (FDLI) Annual Conference on 6 May. During a panel discussion, an attorney and officials from the medical device industry discussed the implications of the QMSR, which permits FDA inspectors to review the internal audits conducted by companies. Before QMSR, these records were confidential and not subject to FDA review.
Thomas informed the meeting that the agency has conducted “just north of 100” inspections under QMSR so far. The regulation went into effect on 2 February 2026.
On 31 January 2024, FDA published its QMSR final rule that has been years in the making. This rule amends FDA’s current medical device good manufacturing practice (CGMP) expectations under its quality system (QS) regulation to align with ISO 13485:2016. (RELATED: FDA issues QMSR final rule with 2-year transition period, Regulatory Focus 31 January 2024)
“Risk management is the top observation,” Thomas said, noting that there is a significant emphasis on risk management within QMSR. “Risk, risk, risk, risk. That is the fundamental change to QMSR. Risk is central to all the activities of the quality management system, and it is expected that all of your processes will involve risk,” she said.
After risk management, the top observations are related to outsourcing problems, followed by inadequate complaint handling, and unique device identification (UDI) system issues. Violations tied to corrective actions rank fourth on the list. The period for issuing these observations was February to mid-April.
Thomas said that other major changes in the QMSR is the addition of the culture of quality piece, as well as FDA’s right to review the results of internal audits. QMSR grants investigators the authority to review internal audit reports, supplier audits, and management review records, and aligns closely with ISO 13485:2016.
Thomas said that the FDA must have a reason to inspect these files unless there is a reason for doing so. For example, if risk management violations are found, FDA may want to look at these internal files.
The moderator of the session. Jennifer Newberger, an attorney with Hyman, Phelps & McNamara, called the internal audit piece of QMSR a “huge change” and asked her colleagues on the panel to comment on whether this means that firms will be less transparent about what they note in internal records if they know these records could be inspected by the FDA.
Philip Desjardins, an attorney with Arnold Porter, mentioned that these issues have not yet been raised to him, but it's still too early to determine the outcome.
Jaimi Gaffe, an attorney with Johnson & Johnson, stated that the company has been conducting training to ensure their staff is aware of this change. They are also being “more careful” of the language used in internal audits to ensure that the context is accurately presented.
