Welcome to Insider issue #51.
Also, hello to the 522 life science professionals who joined us last month. If you haven’t already upgraded to a paid subscription to unlock our in-depth analysis issues like this one, you can do so here. Read our past deep dives here.
This month, Anindita Deogharia walks through the June 2026 guidance on postapproval requirements for ANDAs. The obligations themselves didn’t change. What changed is where they live, and that has a practical consequence: your approval letter is no longer your compliance checklist.
Jesse Hart takes apart a significant medical device warning letter. Four product lines, a year of monthly responses, and the FDA still saying no. Jesse’s read is that this isn’t six separate findings. It’s one broken loop the agency happened to document six different ways, and he lays out how to check whether your own system has the same gap.
Jonathan Wacks closes with the warning letter to a Montreal aseptic filling facility. Deficient smoke studies, media fills that never simulated realistic disruptions, and mold growth on filling employees that nobody chased down. Jonathan spent years doing QA in this space and doesn’t mince words about what it takes to run a sterile operation.
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