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What QA doesn't know... Five weeks after FDA's first warning letter citing AI overreliance, the implications are still being underestimated — particularly outside pharma. On April 2, the FDA issued the first warning letter in the agency's history with a dedicated section titled Inappropriate Use of Artificial Intelligence in Pharmaceutical Manufacturing. The recipient was Purolea Cosmetics Lab, a Livonia, Michigan contract manufacturer that produces homeopathic OTC drug pro

What FDA's May 6 announcement actually changes about how you prepare for inspection — and why "low-risk" isn't the win it sounds like. On May 6, FDA quietly redrew the inspection map. There were two announcements out of White Oak that day, and most of the trade press treated them as separate news. They aren't. Read together, they tell you that the inspection process you have trained your team for — the one that begins when an investigator presents credentials at your front de

A regulatory and clinical reality check for hospital leaders, quality teams, and the device industry that serves them. About one in four people in a U.S. hospital bed has diabetes or hyperglycemia.¹ Almost none of the continuous glucose monitors used to manage them in 2026 is actually FDA-cleared for that setting.² The COVID-era enforcement discretion that briefly made hospital CGM use legitimate expired on November 7, 2023.³ Two and a half years later, the devices are still

By Ricki A. Chase | April 2026 | RChase Consulting LLC There is a narrative circulating in certain boardrooms and quality departments right now that goes something like this: FDA is distracted. They've lost thousands of employees. Inspections are down. We have some breathing room. After 28+ years working in and around FDA — including as Director of Investigations — I want to be direct with you: that narrative is dangerous, and it will cost you. Yes, FDA has experienced signif

Much ado about nothing? Or a wake-up call for medical device manufacturers? As the FDA's new Quality Management System Regulation (QMSR) approaches its effective date of February 2, 2026, one change sparking heated debate is the agency's expanded access to internal audit reports and management reviews. While these have long been fair game under existing regulations, FDA policy historically shielded them from routine inspections. Now, with QMSR harmonizing the Quality System R

Having read several articles on LinkedIn and held many spirited conversations with ex-FDA colleagues, I wanted to offer a perhaps different perspective on the move from specialized investigative staff back to a more generalist approach. The History of FDA Investigators Most are familiar with the history. The FDA's Office of Regulatory Affairs (ORA) traditionally operated with investigators starting as generalists, honing their skills in food programs—particularly general sani

Last week, I shared insights on the FDA's upcoming review of internal audits and management reviews under the new Quality Management System Regulation (QMSR), set to take effect on February 2, 2026. Today, let's connect that to the vital concept of quality culture. The pharmaceutical industry has long emphasized quality culture, with the Center for Drug Evaluation and Research (CDER) introducing the Quality Management Maturity (QMM) program to systematically evaluate and rate

The medical device industry is one of the most regulated sectors in the world. With the increasing complexity of devices and the rapid pace of technological advancements, ensuring compliance with the Food and Drug Administration (FDA) regulations is crucial for manufacturers. Understanding the FDA's requirements can be daunting, but it is essential for the safety and efficacy of medical devices. This blog post will guide you through the key aspects of FDA compliance, providin

Navigating the regulatory landscape can be challenging, especially when faced with an FDA warning letter. These letters can have significant implications for companies in the healthcare, pharmaceutical, and food industries. Understanding how to respond strategically is crucial for maintaining compliance and protecting your business's reputation. In this blog post, we will explore effective strategies for responding to FDA warning letters, ensuring that your organization is pr

In the world of regulatory affairs, the stakes are high. A well-prepared regulatory submission can mean the difference between a product reaching the market or being delayed indefinitely. Understanding the essentials of effective regulatory submissions is crucial for professionals in the field. This blog post will guide you through the key components, best practices, and common pitfalls to avoid when preparing regulatory submissions. Understanding Regulatory Submissions Regul