FDA 483 - Onkos Surgical, Inc. - April 04, 2025

Onkos Surgical, Inc. received a Form 483 citing significant deficiencies across its quality system, indicating a moderate level of severity. Observations include inadequate control over purchased products and services, failures in nonconformance investigations and CAPA execution, and ineffective risk management for its ELEOS implantable system. The firm also failed to report device corrections and removals that posed health risks to the FDA.