FDA 483 - Shikani Medical, LLC dba The Airway Company - December 21, 2023

During an FDA inspection from December 18-21, 2023, Shikani Medical, LLC dba The Airway Company was cited for numerous violations of the Quality System Regulation (21 CFR Part 820). The inspection revealed significant systemic deficiencies in their quality management system, critical for medical device manufacturing.

Key issues included a prolonged absence of management reviews and internal quality audits since 2015, the failure to appoint a management representative, and the use of obsolete quality system documentation. The design history file for their Shikani Speaking Valve device was incomplete, lacking essential design control records and proper risk mitigation. Additionally, the company failed to generate records for customer complaints, adequately inspect and accept incoming finished products, and properly evaluate and approve suppliers and consultants. Employee training records were also largely absent or insufficient.

These observations indicate a comprehensive failure to establish and maintain an effective quality system. Shikani Medical, LLC is expected to implement thorough corrective actions to address these findings and ensure full compliance with FDA regulations, as indicated by their commitment to correct each observation.