George Kwiecinski

George Kwiecinski, Global Key Solutions Corp

connected with George Kwiecinski, CEO and co-founder of Global Key Solutions Corp, to discuss FDA GMP inspection trends, supplier oversight gaps, and the rising regulatory scrutiny of AI in pharma compliance.

Watch the full video interview with George Kwiecinski:


George Kwiecinski on Why Now Is the Time to Reassess Your GMP Audit Strategy

PT: How Should Quality and Compliance Teams Prioritize Foreign Suppliers for Audit or Reinspection when Inspection Coverage Is Limited?

Kwiecinski: It comes down to resources and organizational capacity. Whether you're inspecting an internal facility or auditing a supplier, most organizations are working within real constraints. The question becomes: are you procuring the right tools and technology to make sound assessments? Are you selecting suppliers through a documented, demonstrable process? These aren't just best practices, they're expectations. With the QMSR changes affecting both medical devices and the FDA's ability to scrutinize internal audit documentation, this has become a hot-button issue. Organizations need to take a second look at how those processes are being handled and reprioritize accordingly. The good news is that tech stacks have improved significantly for most workflows, so there's really no excuse not to reassess.

What's Your Outlook on Compliance Risk in Global Supply Chains?

Honestly, I don't think the fundamental risk picture changes dramatically. The top citation areas will continue to revolve around the quality unit, drug efficacy and safety standards, and how those standards are being enforced across vendors. Those core pillars aren't going anywhere. What will shift is the context around them, especially as new technologies and practices become more common in the industry.

How can AI-powered Regulatory Intelligence Improve Oversight without Providing False Positives or Incomplete Data?

Yes, this is something we've been tracking closely. One trend that really made waves recently was that an AI citation appearing in an FDA warning letter. Essentially, a company had used AI to respond to the FDA and generate some of their documentation, and that usage was called out directly. Now, I think this kind of citation will become more frequent over time. It may not always be flagged explicitly, but AI use in regulatory processes is clearly on the FDA's radar.

We put together a white paper recently looking at how the FDA has used ‘AI’ as a keyword across its correspondence and documentation over the last 3-4 years. What we found was telling: there are now 5 distinct regulatory correspondences specifically referencing AI, and over 20 FDA guidance and documents that mention it, with the frequency increasing steadily over time. That trajectory tells us that AI is becoming a meaningful part of the agency's regulatory purview, and companies need to start thinking about what that means for them.

What Changes Do You Recommend to Strengthen Foreign Supplier Governance when API and Finished-dose Sourcing Is Heavily Concentrated Overseas?

The first step is just awareness, understanding that these changes are happening and that it's accelerating. From there, it's about looking at your own tech stack and honestly evaluating how your organization is managing AI-related risk. If your organization is using AI tools in any part of its regulatory or quality workflow, you need to be thoughtful about how those decisions are documented and defended.

As for whether companies should invest in new AI tools, I think that's a legitimate conversation to have, but the justification has to be grounded in business reality. If a tool can demonstrably save cost or drive profit, and you can implement it in a safe, controlled way, then pursuing it makes sense. What's going to matter most though, is the risk-based approach: how are you accounting for AI-assisted or AI-driven decisions within your processes? That's exactly the kind of thing that's subject to FDA scrutiny right now.

Articles

Global supplier oversight remains constrained by finite audit resources, elevating the importance of documented, defensible risk prioritization and fit-for-purpose technology. Persistent GMP citation drivers—quality unit effectiveness and enforcement of efficacy/safety standards across vendors—are expected to continue, but will be reframed by expanding use of AI in quality and regulatory workflows. FDA attention to AI is increasing, including explicit mention in warning-letter context and growing references across agency correspondences and guidances. Organizations should reassess audit strategies, strengthen governance of overseas sourcing, and formalize controls for AI-assisted decisions.

George Kwiecinski, Global Key Solutions Corp, breaks down GMP inspection risks, global supply chain compliance, and AI's growing role in FDA regulatory scrutiny.

Q&A: George Kwiecinski on How AI Is Reshaping FDA Regulatory Compliance

At INTERPHEX 2026, George Kwiecinski examines FDA GMP inspection trends, supplier oversight gaps, and the rising regulatory scrutiny of AI in pharma compliance.

, George Kwiecinski, CEO and co-founder of Global Key Solutions Corp, discusses FDA GMP inspections and the evolving compliance landscape for both domestic and foreign manufacturers.

Kwiecinski opens by emphasizing inspection coverage as a foundational concern, specifically whether organizations have the right tools, technology, and documentation practices to properly assess and select their suppliers. With recent quality management system regulation changes expanding the FDA's ability to scrutinize internal audit documentation for medical devices, supplier oversight has become a particularly hot-button issue. He argues that improved technology stacks make this an ideal moment for companies to reassess and reprioritize their audit workflows.

On the broader compliance risk landscape, Kwiecinski expects the core FDA citation categories—quality unit deficiencies, drug efficacy and safety standards, and vendor enforcement—to remain stable, but he highlights an AI citation appearing in an FDA warning letter. A company had used AI to generate regulatory documentation, drawing formal scrutiny. He sees this as a signal of things to come, urging companies to examine how their organizations are managing AI-related risks.

Kwiecinski backs this up with data from a white paper his firm recently published, tracking the FDA's use of AI as a keyword across regulatory correspondences over the past three to four years. The findings indicate that AI mentions are growing in frequency, now spanning five regulatory correspondences and more than twenty FDA guidance documents. His guidance to industry is to adopt AI tools if they demonstrably save cost or drive profit, but approach the risk-based framework governing AI-assisted decisions with care, as that is precisely where FDA scrutiny is heading.