We just broke down a recent warning letter to a domestic device firm that, unlike many, isn’t about missing SOPs. It’s about what happens when known issues stall.

The FDA documents long-open complaints tied to implantable devices, CAPAs that fixed conditions but never assessed patient impact, and risk files that didn’t absorb what the quality system was already signaling.

If you work in devices, this one is worth reading. It’s a case study in how routine gaps in ownership, follow-through, and risk escalation compound fast.