The FDA’s Office of Pharmaceutical Quality report for the 2024 financial year (FY2024) has been released. It offers a detailed picture of the global pharmaceutical manufacturing landscape, postmarket quality trends, regulatory enforcement, and the agency’s evolving surveillance methods.
By the end of FY2024, the Center for Drug Evaluation and Research (CDER) Site Catalog listed 4,619 manufacturing sites worldwide, with 41 percent in the US. Over the past five years, the number of registered sites rose 11 percent, largely driven by “No Application” sector facilities – manufacturers producing only non-application products such as unapproved prescription drugs and homeopathic remedies. Countries showing the biggest growth in sites include China (+27 percent), Spain (+20 percent), Germany (+19 percent), India (+18 percent), and South Korea (+16 percent).
Inspection activity has also increased post-pandemic, with 972 FDA drug quality assurance inspections conducted in FY2024 – a 27 percent increase from 2023. More than 62 percent of these inspections occurred at foreign sites, with India and China seeing particularly high coverage.
Globally, 93 percent of sites had favorable inspection outcomes (no action indicated or voluntary action indicated), but regional differences exist. Europe, for example, can be proud of its 98 percent favorable inspection outcomes, while India has a bit more work to do to catch up at 87 percent.
CDER’s Product Catalog now includes 383 biologics licensing applications including 63 biosimilars – a 47 percent increase from FY2023. The catalog also contains 14,168 abbreviated new drug applications, up 4.4 percent, 3,625 new drug applications (+0.9 percent), and over 140,000 non-application national drug codes (+6.7 percent). The total product count grew by 6.3 percent in FY2024, echoing the prior year’s growth.
Recalls, warning letters and enforcement
In FY2024, 75 sites were added to quality-related import alerts, with the majority (65 percent) manufacturing OTC monograph products. Notably, API manufacturers made up 25 percent of import alert additions, reflecting heightened scrutiny of bulk API suppliers to domestic compounding pharmacies. Over the past five years, 72 percent of regulatory actions against API makers targeted those serving only compounding pharmacies, despite representing just 18 percent of API manufacturers.
There were 421 recalled products in FY2024 – the lowest in five years – despite a 15 percent increase in recall events (260 in total). Contamination was the top defect category, ranging from microbial issues to particulates. CGMP-related recalls dropped to 24 percent from roughly 50 percent in prior years. Ophthalmic agents led all therapeutic classes in recall frequency. Stability failures, particularly dissolution and impurity issues, were common in products flagged for failed specifications.
105 drug-quality-related warning letters were issued in FY2024, the highest in five years. While US domestic warning letters fell, an increase was observed in the rest of the world, driven by more inspections abroad and quality issues flagged. South Korea-based OTC manufacturers received multiple citations for failing to test for toxic contaminants such as DEG/EG and methanol.
In summary
More than 60 percent of inspections were conducted abroad, and mutual recognition agreement partnerships are at record use levels. High inspection rates were seen in India and China.
The OTC and API sectors are under the highest scrutiny, particularly where APIs feed into compounding pharmacies, signalling a priority oversight due to disproportionate compliance issues.
The FDA is expanding its ability to spot early quality signals and intervene.
The surge in warning letters, especially for foreign sites, reflects heightened enforcement tied to both inspections and document request compliance.
While overall product recall counts dropped, contamination remains a critical risk area, and stability failures are an emerging concern.
Catching up from pandemic-era inspection slowdowns and actively expanding its surveillance toolkit, the FDA appears to be tightening supply chain oversight and targeting high-risk sectors with data-driven precision. Companies should be prepared for deeper scrutiny, more proactive data requests, and an expectation that quality assurance extends across global networks and supply chains.
A focus on ADHD drugs
The FDA has also shown in this report its ability to combine different types of data to get a complete picture of medicine quality and availability. For drugs used to treat attention-deficit/hyperactivity disorder (ADHD), the FDA pulled together information on shortages, quality problem reports, product recalls, new product approvals, and the manufacturing and supply networks.
For stimulant ADHD medicines, which are limited by production quotas set by the Drug Enforcement Administration (DEA), the FDA found that supply chains were complex and mostly within the United States. These products also had more quality problem reports through the MedWatch system (the FDA’s program for reporting safety and quality issues), more recalls, and more frequent shortages.
In contrast, non-stimulant ADHD medicines had steady supply, few quality problems, no recent shortages, and simpler supply chains that were mostly based outside the United States.
By bringing all this information together, the FDA can spot problems more quickly and take targeted action to help prevent or ease shortages.
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