FDA 483 - Onkos Surgical, Inc. - April 25, 2023

An FDA inspection conducted between August 14 and August 25, 2023, identified significant deficiencies at Redacted, a contract manufacturer and laboratory. The inspection revealed a widespread failure to establish and implement essential quality system procedures and maintain required documentation, indicating non-compliance with the U.S. Food and Drug Administration's Quality System regulation (21 CFR Part 820) for medical devices.

Key observations included the absence of critical procedures for Corrective and Preventive Action (CAPA), Complaint Handling, Design Validation, Purchasing Control, Production and Process Control, Quality Audits, Management Review, Nonconforming Product, Production and Process Changes, Acceptance Activities, Training, Rework, and Design Control. Furthermore, the firm failed to maintain Device Master Records for its products. A particularly concerning aspect is that many of these issues, such as the lack of CAPA and Complaint Handling procedures, were repeat observations from a previous inspection in January 2016, demonstrating a persistent lapse in compliance.

To address these findings, Redacted is required to develop, establish, and effectively implement a comprehensive set of quality system procedures and ensure all necessary records are created and maintained to meet regulatory requirements.