Top 7 FDA Inspection Findings in Medical Device Companies in 2024

In 2024, the FDA remains focused on ensuring that medical device companies adhere to stringent regulatory requirements to guarantee patient safety and product quality. With rapidly evolving technology and the growing prevalence of connected devices, the FDA’s inspection findings highlight critical areas where manufacturers often struggle to comply. Understanding these common findings can help companies proactively improve their quality systems and avoid potential enforcement actions.

1. Design Control Deficiencies

Design control has consistently been an area of concern in FDA inspections. In 2024, the FDA observed multiple instances where companies failed to establish and maintain adequate design control processes, particularly for complex or software-driven devices. Common issues include:

• Inadequate risk management procedures.
• Lack of clear documentation on design inputs and outputs.
• Insufficient or incomplete design verification and validation activities.

In some cases, manufacturers failed to update their design history files (DHFs) after changes, potentially risking product safety. These findings underscore the need for companies to adopt a risk-based approach, continuously revisiting design inputs and outputs to align with the latest patient safety standards.

2. Inadequate Corrective and Preventive Action (CAPA) Systems

CAPA is a cornerstone of quality management, but the FDA still frequently finds non-compliance in this area. CAPA deficiencies in 2024 included:

• Poor root cause analysis and lack of objective evidence to support corrective actions.
• Insufficient tracking of CAPA effectiveness.
• Delays in implementing corrective actions, leaving potential risks unaddressed.

To address these concerns, manufacturers should employ data-driven CAPA practices that enable timely, evidence-based decision-making. This can involve using data analytics to prioritize CAPAs based on risk levels and root causes.

3. Quality System Documentation and Record-Keeping Issues

FDA inspections continue to highlight record-keeping as a critical area of non-compliance. In 2024, inspectors observed instances where medical device companies failed to:

• Maintain accurate and complete records of quality audits.
• Properly document training records for staff involved in quality-critical processes.
• Keep an updated, well-organized Device Master Record (DMR) that is accessible during inspections.

An effective quality management system should include robust documentation controls, with periodic audits to ensure completeness, accuracy, and traceability.

4. Cybersecurity Risks and Lack of Preparedness

With the FDA’s heightened focus on cybersecurity, especially following the recent cybersecurity guidelines for medical devices, many companies have struggled to implement and document effective cybersecurity measures. Key findings in 2024 include:

• Inadequate identification of cybersecurity risks during the design and development phase.
• Lack of proper monitoring and response plans for post-market cybersecurity threats.
• Insufficient employee training on cybersecurity best practices.

To mitigate cybersecurity risks, manufacturers should conduct thorough risk assessments and integrate security features throughout the device lifecycle. Regular employee training and cybersecurity drills are also essential to prepare staff to respond to potential threats.

5. Non-compliance with Supplier Controls

In 2024, the FDA has continued to emphasize the importance of supplier control as more medical device companies rely on complex supply chains. Common findings related to supplier controls included:

• Failure to properly evaluate and monitor suppliers’ quality systems.
• Inadequate supplier agreements that fail to define quality expectations.
• Lack of sufficient incoming inspection to verify that purchased materials and components meet specifications.

An effective supplier control program is essential for quality assurance. Manufacturers should regularly audit their suppliers, establish clear quality agreements, and implement rigorous incoming inspection procedures to reduce the risk of quality issues from outsourced components.

6. Production and Process Control Weaknesses

Process control issues have remained a focal point for the FDA in 2024, particularly as device complexity increases. Findings in this area often involve:

• Inadequate process validation, especially for new or modified manufacturing processes.
• Lack of controls to ensure consistency in production output.
• Poorly documented procedures that result in variability and quality inconsistencies.

To address these issues, companies should invest in robust process validation, particularly for high-risk processes. Statistical process control (SPC) and regular audits can also help maintain consistent production quality.

7. Lack of Compliance with UDI Requirements

Unique Device Identification (UDI) is crucial for device traceability and post-market surveillance, yet some companies still fail to comply fully with UDI requirements. In 2024, the FDA observed:

• Missing or incorrect UDI labeling on certain device classes.
• Incomplete UDI record submissions to the Global Unique Device Identification Database (GUDID).
• Lack of internal controls for managing UDI information.

To avoid non-compliance, manufacturers should ensure that UDI requirements are integrated into their production and documentation processes. Regular audits and cross-functional training can also help maintain consistent compliance.

Key Takeaways

In 2024, the FDA’s top inspection findings underscore the importance of comprehensive quality systems and proactive compliance measures. Medical device companies should focus on:

• Strengthening design control and cybersecurity measures to keep pace with regulatory expectations.
• Enhancing CAPA processes with data analytics and timely corrective actions.
• Improving documentation practices to support inspection readiness.
• Ensuring effective supplier and production controls for consistent product quality.

Staying informed about FDA priorities and leveraging internal audits can help medical device manufacturers navigate regulatory challenges, protect patient safety, and maintain market access. By addressing these common inspection findings, medical device companies can enhance their quality systems and minimize the risk of non-compliance in future FDA inspections.

Support for Your Quality Assurance and Regulatory Compliance Needs

Navigating the FDA Quality & Regulatory landscape can be challenging, especially while balancing day-to-day operations. PRP offers expert Quality Assurance and Regulatory Compliance support for medical devices and pharmaceuticals. Our team of experienced consultants across the country is ready to seamlessly integrate with your team, helping you maintain compliance and the highest quality standards. Book an appointment with our CEO, Stefanie Wichansky to discuss how we can support your compliance goals.