The Structural Problems Causing the Pharma and Biotech Industries’ Compliance Failures

In July of this year, Krieger Scientific issued a release addressing the increase in 303 drug warning letters issued by FDA. In 2025, as new leadership took over the agency, FDA sent 303 drug warning letters, up 59% from the previous year.¹

Krieger’s founder and CEO Joseph Morwald believes that the increase is the result of structural problems within the industry. In his original statement, he said, “The FDA recommended outside compliance expertise in 87 percent of the warning letters it reviewed last year. That is not a coincidence. That is a diagnosis. When validation, calibration, and quality functions are managed in silos, by phase, by vendor, by department, with no single point of accountability, organizations lose the ability to catch problems before they become violations.”

Morwald spoke with Pharmaceutical Executive about the increase in warning letters and what he sees as the exact issues causing it. According to him, new technologies may be pushing companies away from human expertise, resulting in an increase in issues.

Pharmaceutical Executive: What structural problems are causing the industry's compliance failures?
Joseph Morwald: When we look at structural problems within companies, there's a lot of disjointedness and disorganization — siloed segments of the business operating without uniform systems and processes. There are too many computerized systems that don't talk to each other, with no APIs linking software together. The result is multiple databases tracking and managing similar data in ways that are fundamentally out of sync. I like to use the phrase: a man with two watches never really knows what time it is. The same problem occurs when you have multiple systems trying to track and manage the same information — if you have two databases, which one is correct? If you have three, you're really struggling.

Take asset management as an example. A single piece of equipment might be managed across three entirely separate systems — one from a finance perspective, one from a quality perspective, and one from a maintenance and calibration perspective. Each system is looking at the same asset but through a different lens. Finance is focused on depreciation schedules. Quality is focused on validation status. Maintenance and calibration are tracking whether the equipment is functioning and in spec. Some of the underlying data is the same — manufacturer, model, serial number, unique identifier — but it's being managed, run, and controlled by different groups, departments, and people. So those systems become disjointed and out of sync, and that is a major issue.

Historically, this was all managed on paper, and it was disjointed then too. But now we have less experienced people managing these silos, and the problem is compounding. Equipment and assets are not treated consistently across departments. Everyone has a singular function, and people are so focused on getting their own tasks completed that they're not thinking about the downstream impact on the rest of the organization.

Maintenance and calibration see that something is broken and fix it — without stopping to consider what the finance department is looking at from the same asset. Is it worth fixing? Is it past its depreciation schedule? Should it be replaced? When no one is looking at the full picture, spend becomes uncontrolled, replacements become reactive, and costs spiral. The organization is only ever seeing small pieces of a problem that needs to be viewed as a whole.

Source

1. FDA Warning Letters Surge 59 Percent. One Life Sciences Firm Says the Industry Is Solving the Wrong Problem. Krieger Scientific. July 9, 2026. Accessed August 5, 2026. https://www.einpresswire.com/article/925352156/fda-warning-letters-surge-59-percent-one-life-sciences-firm-says-the-industry-is-solving-the-wrong-problem