FDA 483 - Stryker Corporation - January 24, 2023

Stryker Corporation in Portage, MI, a medical device establishment, was cited for two significant issues during an FDA inspection. The firm failed to adequately establish procedures for complaint handling, leading to significant delays in reporting MDRs for the C2 Nerve Monitor device, which was subsequently recalled. Additionally, procedures for design validation, particularly for device software, were found to be inadequately established, with issues in defining software units and executing regression testing.