Key highlights and insights for FY2024

Key takeaways from the FY2024 report 

FDA drug quality assurance inspections have nearly doubled over the past two years, with over 62% conducted at foreign sites in FY2024, a record high. This reflects the FDA’s commitment to strong global oversights and strengthens their initiative to perform more unannounced inspections at foreign sites.  

Globally, manufacturing sites located in Europe have the best inspection scores with 98% of sites having no actions (NAI) or voluntary actions indicated (VAI), compared to India which received the lowest scores with 87% of sites receiving the NAI or VAI score.

Both field alert report (FARs) submissions and post market quality reports decreased by 7.5% and 1.5% respectively compared to FY2023. However, biological product deviation reports (BPDRs) increased by 17%, signalling areas that need ongoing vigilance.  

Empowered by the Coronavirus Aid, Relief and Economic Security Act (CARES Act), the FDA improved drug amount reporting. These data were used to optimise the 2025 targeted surveillance inspections scheme to bolster drug supply chain resilience and mitigate possible drug shortages. 

The FDA issued 105 warning letters for drug quality concerns in FY2024 – the most in 5 years. Most of the FY2024 increase was driven by inspection-based warning letters based on the increased number of inspections. The increased number of warning letters underscores the FDA’s strict enforcement based on inspections, record requests and product testing.

The import alert process, in place to monitor and test incoming products related to a violation or potential product quality issue, showed that most alerts were related to sites located in China (39%). A large increase of import alerts was detected for active pharmaceutical ingredient (API) suppliers that service domestic compounding pharmacies. In a lot of cases, these additional alerts weren’t initiated by the FDA but rather on the request of the pharmacies. This is because compounding pharmacies aren’t required to perform incoming tests on received API. In this way, the import alert process becomes an important tool for both the FDA and the local value chain actors to ensure oversight and protect patients when they are unable to inspect foreign sites or perform additional tests.

While contamination remains the top recall cause, the number of recalled products per event hit a five-year low, thanks to proactive FDA quality management strategies to ensure medicine availability.

Nevertheless, when looking at the countries in which the manufacturing sites with the highest number of recalls are located, it can be seen that US sites have the biggest contribution (48%), followed by India (41%).

Conclusion

The FY2024 Report on the State of Pharmaceutical Quality highlights the FDA’s ongoing commitment to public health through rigorous inspections, data-driven decisions and enforcement. The report not only adds value for the US, but it also shares a point of view and understanding of the performance of manufacturing sites across the world. The report shows that companies that have an established culture of quality, based on mock inspections, controlled processes, robust systems and people willingness, not only score high on quality compliance but also have strong outcomes for business excellence.

This culture of quality is mainly noticed at manufacturing sites located Europe – a positive trend we observe in our engagements and in which we support our clients. Together with our clients, we strive to improve quality across organisations, improving medicine availability for patients. 

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