FDA 483 - Theos Medical Systems, Inc. - June 16, 2023

An FDA inspection of Theos Medical Systems, Inc., conducted from June 12-16, 2023, identified several significant deficiencies in the company's quality management system, primarily concerning medical device regulations. The inspection highlighted three main issues. First, the firm failed to adequately review and investigate 159 customer complaints received since January 2021, with the CEO stating they were "too small" for formal investigation, and individual complaint files lacked critical information. Second, the company did not document Corrective and Preventive Actions (CAPAs) for previous quality system corrections made in 2014 and 2016, omitting essential investigations, root cause analyses, and effectiveness checks. Third, the management representative did not ensure the quality system's effective establishment and maintenance, as key quality data sources like CAPAs, complaints, and statistical analyses were not incorporated into the last Management Review, dated August 19, 2022. These observations indicate non-compliance with quality system requirements under the Federal Food, Drug, and Cosmetic Act. Theos Medical Systems, Inc. has committed to correcting all identified issues.