Day: January 20, 2022

Several 3D printed devices may be printed at the clinic rather than printed at a traditional manufacturing facility and shipped. But 3D printing operations still need to comply with FDA’s QSR and GMP requirements. FDA released a Discussion Paper listing three scenarios for 3D printed devices with examples and tips for complying with FDA’s requirements … Read more

FDA has increasingly relied on remote inspections of manufacturing facilities since March 2020. It announced resumption of the normal on-site inspections a few times since then and then re-paused on-site inspections due to the pandemic. Earlier this year, FDA had announced a similar pause in on-site inspections due to the spread of the omicron strain … Read more