A recent FDA warning letter shows what separates a defensible letter to file from a thin one. The difference is the design change assessment behind it, and how well it connects to complaints and CAPA.
RUOs, LDTs, and FDA Enforcement
Despite the 2025 court decision vacating the FDA’s LDT Final Rule, labs and manufacturers aren’t off the hook. This article explores how the FDA is shifting enforcement to RUO labeling and IVD misuse to maintain oversight of unregulated diagnostics.
Your Data, Your Responsibility
Update, August 2026: A third lab, and a distinction worth understanding On June 25, 2025, FDA issued a Good Laboratory Practice warning letter to CCIC Huatongwei International Inspection Co., Ltd. in Suzhou, China, following a January 2025 inspection. The findings...
Warning Letters
Update: This post was written in October 2024 when FDA first announced the action. FDA has since gone further, rejecting all study data from both facilities, and we have written a fuller piece on what this means for your supplier qualification program. For the current...