Every year the FDA compiles its Fiscal Year Report on the State of Pharmaceutical Quality. This report takes a look back at the previous fiscal year and identifies trends throughout CDER and the Office of Pharmaceutical Quality (OPQ) various surveillance activities to assess the state of pharmaceutical quality. Fiscal year 2022’s report card was published last month and provides a great insight into how pharmaceutical manufacturers are navigating a new post-COVID regulatory landscape.

The key demographics that last years report comprises of is more than 4,800 manufacturing sites, 40% of which are located in the United States. Additionally, of the sites included, 40% are also considered within the “No Application” sector, meaning that they manufacture products that can be marketed without an FDA application, including OTC products.[1] Within this report, the FDA reviews several KPI’s, including Essential Medicine supply, product quality defects, recalls, enforcement actions, and the FDA’s sampling/testing program.

Of all the KPI’s covered, the most interesting to me was the section on recalls and warning letters. The FDA provides a variety of deep dives into the data related to issues with all manufacturers across the sector. Within the report card, you can see that in FY2022 most recalls were due to cGMP deviations, temperature abuse, and failed specifications. Lesser amounts of recalls were due to product contamination, defective product, packaging, and labeling. This is particularly interesting because while most people would guess that most recalls would be due to GMP issues, I was surprised to see that temperature abuse and failed specifications were so high up on the list. Additionally, there were more recalls in FY2022 than the previous 4 years. Of all the recalled products last year, the top five recalls by therapeutic area were: respiratory tract agents, cardiovascular agents, analgesics (non-opioid), antibacterials, and gastrointestinal agents.

It is always interesting to see the FDA trends year to year, especially in the pharmaceutical quality space. We have also seen the FDA take a keen interest in how manufacturers are adhering to aseptic practices, how they are assessing and validating their media-fill runs, and how compliant and cohesive their deviation investigations are.

EMMA International can support you with all aspects of pharmaceutical quality and compliance. With global experts who can be at your facility within the week, EMMA International has all your compliance needs covered. Contact us today at 248-987-4497 or email info@emmainternational.com to learn more!


[1] FDA (June 2023) Fiscal Year 2022 Report on the State of Pharmaceutical Quality retrieved on 7/30/2023 from: https://www.fda.gov/media/169611/download?attachment

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