FDA 483 - Theos Medical Systems, Inc. - June 16, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 60265961-066d-4fbe-a51e-95e12daa940c