Category: Uncategorized
Top Reasons Life Sciences Companies Receive FDA Citations
June 2024
Navigating FDA regulations and staying on top of compliance is critical to the success of a company and product safety. Despite rigorous efforts to maintain compliance, many companies still encounter FDA citations. Understanding common pitfalls can help your organization stay compliant and avoid these costly issues.
The FDA’s data has helped us understand where companies are underperforming and highlights an important area life sciences companies struggle to comply with. In Figure 1, we see the top citation over the past 15 years across all FDA program areas is Devices-21 CFR 820.100(a)- Lack of or inadequate procedures.
In the life sciences industry, we see a common problem across the board: proper procedures are either not in place or they are not being followed. Figure 2 shows that most of the top citations for Devices are due to a lack of or inadequate procedures.
The Top 10 Citations for Devices:
- Lack of or inadequate procedures
- Lack of or inadequate complaint procedures
- Lack of written MDR procedures
- Purchasing controls, lack of or inadequate procedures
- Lack of or inadequate process validation
- Nonconforming product, lack of or inadequate procedures
- Documentation
- Quality audits, lack of or inadequate procedures
- Design changes, lack of or inadequate procedures
- DMR- not or inadequately maintained
Similarly, Figure 3 demonstrates that the citations for Drugs vary, but problems with procedures remain the top reason for citations.
The Top 10 Citations for Drugs:
- Procedures not in writing, fully followed
- Investigations of discrepancies, failures
- Scientifically sound laboratory controls
- Absence of written procedures
- Cleaning/Sanitizing/Maintenance
- Testing and release for distribution
- Written procedures not established/followed
- Control procedures to monitor and validate performance
- Calibration/Inspection/Checking not done
- Lack of written stability program
As post-pandemic inspections continue, it is vital to ensure the proper procedures are in place and being followed. Without the proper support in place, these areas can quickly turn into an FDA citation and result in massive financial losses and reputational damage that are difficult to bounce back from.
You can stay on top of regulatory compliance and remediate issues by conducting audits, quality management system gap assessments, and addressing capacity and/or capability gaps with industry-experienced OQSIE consultants.
Want to learn more on how we can help you avoid or resolve FDA citations? Submit a request for more information.
Source: United States Food and Drug Administration’s Data Dashboard
