2 ms·
Clinical diagnostics, for example. Any time you take a blood test and send it off somewhere (Quest, LabCorp, etc.) to get assayed, chances are it goes to a self
by throwup238 3y ago
Clinical diagnostics, for example. Any time you take a blood test and send it off somewhere (Quest, LabCorp, etc.) to get assayed, chances are it goes to a self-regulated and self-inspected lab. These labs hire FDA certified "lab managers" as consultants or employees who are then responsible for all QA/QC procedures and certifying that the lab is capable of doing what they claim. They can be held criminally liable and have quite a bit of authority (a bit like professional engineers) but it's still a cozy employer-employee relationship.
The FDA steps in when something goes really bad but I've never seen them do official spot checks without cause.
- alasdair_ 3y agoWould the Theranos debacle have progressed as far as it did if the FDA inspected at the beginning?