The Top 10 Most Cited QSR Clauses In FDA FY2023 Medical Device Inspections

Female worker in protective workwear working in medical supplies research and production factory and checking packed canisters of distilled water before shipment. Inspection quality control. Industrial warehouse.

New article on Life Science Leader. Adam Atherton, CRE, Consultant, Product Development, outlines the most cited Quality System Regulation (QSR) clauses in FY2023 Medical Device Inspections. 

The FDA’s inspections of medical device manufacturers in FY2023 revealed some persistent challenges around quality system procedures and adherence to key requirements like design controls, CAPA, and complaint handling. While the total number of 483 citations increased by 34% from FY2022, the top cited clauses remained largely unchanged – corrective and preventive actions, complaints, and design controls accounted for over a third of all citations.

A major consistent issue was a lack of adequate procedures across many quality system elements. Nearly 60% of citations for the top 10 most cited clauses stemmed from manufacturers not having properly established procedures. This highlights an area for improvement that may be relatively straightforward to address through developing robust procedures.

Design controls continued to be a significant area of concern, especially around design validation, design changes, and overall procedure gaps. Effective design control processes are critical for ensuring devices meet user needs and intended uses. Related to design controls, risk management practices should be emphasized across the total product lifecycle.

While some fluctuations occurred year-over-year, the data underscores that medical device manufacturers still struggle with some core quality system areas like CAPA, complaint handling, and design controls, which have been top cited issues for many years. Manufacturers should use this analysis to identify potential vulnerabilities in their quality systems and implement remediation efforts accordingly. Developing comprehensive procedures and focusing on design controls with integrated risk management could provide a path toward improved compliance and product quality.

Read on Life Science Leader

About the Author:

Adam Atherton, CRE, is an independent consultant to medical device and combination product manufacturers. He develops strategies to address technical feasibility, new product development, remediation, regulatory, clinical, manufacturing, and post-market surveillance for Fortune 200 medical device and pharmaceutical companies as well as startup ventures. Atherton manages key aspects of design controls, risk management, product architecture, and quality management systems. He holds a Master of Science degree in Electrical Engineering from the Naval Postgraduate School and a Bachelor of Science Degree in Electrical Engineering from California State University, Fresno. He can be reached at

Get in touch if you like to be a guest on the show: