As someone who’s worked in an FDA regulated industry the idea of changing material and design like that without any kind of change control vetting is insane. Sp

As someone who’s worked in an FDA regulated industry the idea of changing material and design like that without any kind of change control vetting is insane. Speaks to an underpowered/ineffectual quality department. Can someone in the automotive space comment if there’s really no legal/regulatory consequence for haphazardly jury rigging stuff on the fly like this?