FDA 483 - CieloWorks, Inc - August 18, 2023

CieloWorks, Inc. in Austin, TX, a medical device establishment, was inspected by the FDA from August 15-18, 2023. The inspection revealed significant deficiencies in the firm's quality system, specifically the failure of management with executive responsibility to conduct regular reviews of the quality system and the complete absence of scheduled or performed quality audits since January 2021. These findings indicate a lack of adherence to established quality management practices.