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

Shikani Medical, LLC dba The Airway Company in Lutherville, MD, was cited for significant deficiencies in its quality management system during an FDA inspection. The firm failed to adequately establish and maintain organizational structure, design controls, complaint handling, incoming product acceptance, supplier management, and employee training. These issues indicate a systemic lack of adherence to regulatory requirements for medical device manufacturing.