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

The FDA inspected Theos Medical Systems, Inc. in Santa Clara, CA, and issued a Form 483 with three observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate complaint handling, a lack of documented corrective and preventive actions, and a failure by management to effectively maintain the quality system through data analysis. These issues indicate a systemic breakdown in ensuring product quality and regulatory compliance.