FDA 483 - Medtronic Xomed, Inc. - October 29, 2021

Medtronic Xomed, Inc. in Jacksonville, FL, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies across multiple quality system areas, including production process controls, corrective and preventive actions, complaint handling, non-conforming product control, and supplier management. These issues indicate a systemic failure to ensure device conformity, investigate failures, and maintain adequate quality oversight.