The Business Risk of Compliance Failures

483s, Warning Letters, or losing an ISO certification can all be bad for business when they become public knowledge and can have a serious negative impact on a company’s reputation. Competitors often use this information to gain market share.

Since reopening onsite inspections after the COVID-19 shutdowns, FDA has substantially increased the number of 483 observations issued and Warning Letters have also increased. For example, in 2021, FDA issued 191 483 observations. In fiscal year 2022, 538 483 observations were issued. The following is a list of the top sources for those observations: 

1. Procedures are not adequately established. This was cited for almost all areas of the QSR.
2. Corrective and Preventive Actions not being adequately documented.
3. Inadequate Process Validations, Design Validations, and Software Validations. 
4. Inadequate Complaint handling and investigation. 
5. Device History Records were inadequate and do not demonstrate the devices were manufactured in accordance with the Device Master Record.  
6. Lack of Supplier controls.  
7. Quality Audits not being performed or not conducted with sufficient frequency and lack of appropriate independence. 
8. Lack of conducting Management Reviews. 
9. Lack of establishing a Design History File. 
10. Not reporting Adverse Events and Adverse Device Events within the required timeframe.
    

How Internal Audits Prevent Compliance Pitfalls

Having a robust Internal Audit program can catch problem areas before an FDA Inspection or External Notified Body Audit. Addressing and documenting issues in a timely manner shows the company is committed to the quality of the products or services provided and continuous improvement of the quality system. This leads to decreased costs for handling customer complaints, nonconforming products, and potentially costly product recalls. A robust Internal Audit program provides management with the information needed to make strategic decisions and provide adequate resources to meet business goals.  

Internal Audits are also valuable for assessing the impact of changing regulations or standards on the quality system. For organizations that are required to be compliant with the current FDA Quality System Regulation (QSR) (21 CFR Part 820), planning should begin in 2025 for the transition to the new Quality Management System Regulation (QMSR) which goes into effect on February 2, 2026. The 2025 Internal Audits are a good opportunity to assess any gaps that may exist or alignment between ISO 13485:2016 and the new QMSR that may be needed.

For larger organizations, there is value in training internal auditors from a variety of departments, not just Quality Assurance. This provides the independence needed for auditing and can add new perspectives. It often provides a better understanding of the pain points experienced across different areas of the company. This promotes a sense of shared responsibility and collaboration for quality throughout the organization. 

Some companies may be very small, and personnel may wear many hats. In these cases, where independence of the internal auditor would be impossible, external quality consultants are able to conduct independent Internal Audits.  

MDC Associates offers experienced, certified, and independent auditors to help ensure compliance and improve your quality system. Contact us today to discuss how we can support your Internal Audit program.