FDA 483 - HAPPE SPINE, LLC. - May 08, 2025

HAPPE SPINE, LLC. in Grand Rapids, MI, a manufacturer of medical devices, received two observations during an FDA inspection. The firm was cited for inadequately documented and ambiguous design input requirements for their HAPPE Spine Cervical Interbody device. Additionally, procedures for the acceptance of incoming products, specifically returned implants and instruments, were not adequately established or documented.