RALEIGH, N.C., June 23, 2026 /PRNewswire/ -- Analysis: Monitoring-related enforcement actions grew nearly 200% between 2021 and 2025, according to a review of 3,286 FDA warning letters
A review of 3,286 FDA warning letters has found that nearly one in three pharmaceutical CGMP warning letters contains explicit references to temperature control or environmental monitoring failures. The number of such letters grew by nearly 200% between 2021 and 2025, rising every single year without exception.
The analysis was conducted by Eupry, a company working with pharmaceutical manufacturers across Europe and the US on environmental monitoring compliance. The findings cover finished pharmaceutical manufacturers, API producers, and compounding pharmacies alike, suggesting the compliance gap is not concentrated in one part of the supply chain but runs across it.
CGMP violations rank among the four most common themes in pharma-relevant FDA warning letters, alongside misbranding and unapproved drug products. Unlike those categories, monitoring failures are both preventable and recurring.
Christian Jacobsen, CEO and co-founder of Eupry, says the trend reflects something deeper than isolated compliance gaps: "Missing data points and disconnected calibration records create an illusion of control. One that outdated systems cannot sustain."
The real cost of a warning letter
When an FDA warning letter cites monitoring failures, every batch of product tied to those systems becomes suspect, triggering quarantines, third-party remediation costs, and eroded trust with partners and patients.
"When an issue escalates to a public warning letter, the FDA is signaling a history of missed alarms and undocumented processes," says Jacobsen. "The organization's quality management infrastructure has deeper cracks than a single monitoring gap."
A problem of structure, not spending.
The persistence of the problem is not primarily a budget or technology issue. Jacobsen points to how compliance infrastructure is built:
"Centralized IT purchases the monitoring solution, while the localized burden of equipment validation and continuous calibration is left as a manual headache for individual facilities. Companies are digitalizing, but putting new software on top of the same fragmented processes."
Until validation, monitoring, and calibration are managed as a unified system rather than three disconnected processes, Jacobsen warns, the trend is unlikely to reverse:
"That 30% failure rate isn't going anywhere."
Notes to editors
Methodology:
Eupry analyzed all 3,286 FDA warning letters published on FDA.gov. Of these, 478 were identified as falling within the pharmaceutical CGMP scope (finished pharmaceuticals, API, and compounding pharmacies) following the removal of food, animal/veterinary, medical device, and dietary supplement categories. Within those 478 letters, 145 (30%) were found to contain high-confidence temperature and environmental monitoring language, based on explicit keyword matching. The true proportion of letters touching on monitoring-related failures is likely higher. Data was collected from the FDA Warning Letters portal in early April 2026, at which point the portal contained 3,286 entries. The portal is updated on a rolling basis; as of today the total stands at 3,562.
About Eupry:
Eupry provides automated temperature and environmental monitoring solutions for the pharmaceutical and life sciences industries, helping organizations move from manual, fragmented compliance processes to unified, continuous monitoring ecosystems.
Press contact:
Cecilie Winther Jørgensen, cwj@eupry.com
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