Welcome to Insider issue #53.
Also, hello to the 310 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This month, Leon Chagal opens with FDA's August 2026 draft guidance on container closure systems, which would trade the existing predefined testing exercise for a product-specific risk assessment that runs from development through every postapproval change. He covers the five risk factors, the 1.5 mcg/day safety concern threshold, and why a container that worked for one drug doesn't automatically qualify for the next.
Kittu Rao reads out a warning letter from the dialysis chair. Lots went out with endotoxin results above specification, the paperwork said they passed, and the only endotoxin instrument had never been calibrated. Kittu takes care of dialysis patients, and his recommendations come straight from the clinic.
Jonathan Wacks closes with a private-label eye drop maker that, according to the warning letter, kept releasing sterile product after three failed media fills and drew a second warning letter for problems the FDA first cited in 2023. The firm suspended production and recalled more than 3 million bottles. Jonathan explains what a failed media fill should set in motion, and why every ophthalmic manufacturer (and other firms, too) should read this letter.
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