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

In Part 1 of a two-part interview at INTERPHEX 2026, 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.