The Significance of FDA’s First Warning Letter for Inappropriate Use of AI

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 is the significance of FDA sending its first warning letter about inappropriate use of AI?
Joseph Morwald: When it comes to AI, there is a significant amount of phantom and ghost information in the space — and when something is generated by an AI tool, you must verify what is real and what is not. We are seeing significant examples of references in documentation that are completely fabricated. This problem exists beyond life sciences, but in life sciences it carries a different weight entirely. We are talking about people's lives — health and safety, life and death — in the manufacture of pharmaceuticals, vaccines, and medical devices. If we get it wrong, people die.

If we are not verifying reference material, not conducting the right tests, not producing accurate and factual data — if we are relying on made-up information, information that doesn't apply, or missing critical steps entirely — the consequences are fatal. That is not hypothetical. That is the reality of this industry.

The FDA recognizes this, and their position is clear: there must be a human in the loop to close the circle on anything generated by AI. It has to be reviewed. It has to be verified. And it must be credible.

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